MAUDE Adverse Event Report: COVIDIEN ENDO CATCH 10MMGOLD; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Model Number 173050G

Device Problems Material Rupture (1546); Material Split, Cut or Torn (4008)

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

Event Date 02/22/2020

Event Type  malfunction  

Event Description

Covidien endo catch gold specimen bag ref (b)(4) broke (tear) in the abdominal cavity of pt during surgery.All parts of endo bag inspected to make sure none left in pt.Event reacted pt, but no harm was evident.Procedure: laparoscopic appendectomy.Wound classification changed.Op note: the appendix was finally isolated and transected with a power gia stapler.This was then placed in an endopouch, which ruptured while i was retrieving it through the left lower quadrant incision.I had to use another endopouch (endocatch 12mm catch 12 used) in order to get the entire specimen from the abdominal cavity.Fda safety report id# (b)(4).

• Brand Name: ENDO CATCH 10MMGOLD
• Type of Device: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 9800463
• MDR Text Key: 182624408
• Report Number: MW5093567
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/04/2020

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 Model Number: 173050G
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/05/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Weight: 97