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Surgical Endoscopy

, Volume 27, Issue 1, pp 86–89 | Cite as

The unacknowledged incidence of laparoscopic stapler malfunction

  • Douglas KwazneskiIIEmail author
  • Cheryl Six
  • Kurt Stahlfeld
Article

Abstract

Background

Laparoscopic instruments are being used with increasing frequency. Our surgeons recently experienced several independent adverse events involving the laparoscopic linear stapler. Although the Food and Drug Administration maintains a Manufacturer and User Facility Device Experience (MAUDE) database to track such voluntary reports, many events are not reported and the true incidence of adverse events is unknown. We attempted to determine how frequently minimally invasive surgeons have experienced technical problems with a laparoscopic stapler.

Methods

Following IRB approval, we electronically distributed an anonymous 10-question survey to the 124 minimally invasive program directors listed in the Fellowship Council database. The questions focused on personal or peer experience with laparoscopic stapler malfunction, frequency and type of malfunction, device manufacturer, whether the operation was altered, and root cause analysis of the event.

Results

Forty-four of the 124 program directors (35 %) completed the survey. The majority reported personal or peer experience (86 %) with a linear stapler not releasing (66 %) or not firing (73 %) after application, with 27 % of the respondents noting that this occurred three or more times. The malfunction was not related to type of load, straight (23 %) or reticulating (32 %) model, or manufacturer (Ethicon 30 %, Covidien 36 %). One quarter of the respondents noted that the malfunction caused them to significantly alter their operative procedure, and 30 % reported that they received no helpful feedback from the manufacturer despite contacting it.

Conclusions

Most minimally invasive surgeons have experienced laparoscopic linear stapler malfunction and 25 % have had to significantly alter the planned operative procedure due to the malfunction.

Keywords

Clinical papers Trials Research Education Instruments Complications Linear staplers 

Notes

Disclosures

Drs. Kwazneski, Six, and Stahlfeld have no conflicts of interest or financial ties to disclose.

References

  1. 1.
    Fellowship Council (2011) Directory of Fellowships. https://fellowshipcouncil.org/directory/browse.php. Accessed Jan 2011
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    Brown SL, Woo EK (2004) Surgical stapler-associated fatalities and adverse events reported to the Food and Drug Administration. J Am Coll Surg 199:374–381PubMedCrossRefGoogle Scholar
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    Champion JK, Williams MD (2003) Prospective randomized comparison of linear staplers during laparoscopic Roux-en-Y gastric bypass. Obes Surg 13:855–859PubMedCrossRefGoogle Scholar
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    Bard V, Cohen Z, Ross T (1993) An unusual intraoperative complication of stapled colorectal anastomosis: report of a case and review of the literature. Can J Surg 36:165–168PubMedGoogle Scholar

Copyright information

© Springer Science+Business Media, LLC 2012

Authors and Affiliations

  • Douglas KwazneskiII
    • 1
    Email author
  • Cheryl Six
    • 1
  • Kurt Stahlfeld
    • 1
  1. 1.Department of SurgeryUniversity of Pittsburgh Medical Center MercyPittsburghUSA

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