MAUDE Adverse Event Report: ETHICON ENDO-SURGERY LLC ENDOPOUCH RETRIEVER; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number POUCH

Device Problem Entrapment of Device (1212)

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

Event Date 02/11/2018

Event Type  malfunction  

Event Description

A 10 mm endo pouch holders cut through the bag.Metal holders grabbed the omentum.Omentum carefully released.No injury noted per surgeon.

• Brand Name: ENDOPOUCH RETRIEVER
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY LLC; cincinnati OH 45242
• MDR Report Key: 7313077
• MDR Text Key: 101614260
• Report Number: MW5075639
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: POUCH
• Device Catalogue Number: POUCH
• Device Lot Number: P4T72D
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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: 5 YR
• Patient Weight: 28