MAUDE Adverse Event Report: COVIDIEN LP ENDO GIA; STAPLE, IMPLANTABLE

Lot Number P8K1522X

Device Problems Crack (1135); Physical Resistance/Sticking (4012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/16/2019

Event Type  malfunction  

Event Description

Upon firing endo gia stapler, heard a loud crack from the handle and the staple was stuck on the bowel tissue.Upon contacting, covidien rep was instructed to pull back on the black tabs which then released the staple.Bowel was partially stapled and cut.This resulted in a larger incision for the resection.Manufacturer response for stapler, covidien radial load stapler (per site reporter).Rep assisted with removing device from patient.Unknown if additional information has been provided by manufacturer.

• Brand Name: ENDO GIA
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP; 710 medtronic parkway; minneapolis MN 55432 5604
• MDR Report Key: 8394190
• MDR Text Key: 137972989
• Report Number: 8394190
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/18/2019,02/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: P8K1522X
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/18/2019
• Event Location: Hospital
• Date Report to Manufacturer: 03/06/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/06/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 19345 DA