MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, INC. ENDOPOUCH RETRIEVER; ACCESSORY, ENDOSCOPE

Lot Number M4HW6M

Device Problem Structural Problem (2506)

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

Event Date 09/11/2015

Event Type  malfunction  

Event Description

Prior to surgery, it was noted that the pouch didn't open.This was not inserted and another endopouch retriever was obtained.

• Brand Name: ENDOPOUCH RETRIEVER
• Type of Device: ACCESSORY, ENDOSCOPE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, INC.; 4545 creek road,; cincinnati, OH 45242
• MDR Report Key: 5165037
• MDR Text Key: 28836938
• Report Number: 5165037
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Unknown
• Device Expiration Date: 07/01/2020
• Device Lot Number: M4HW6M
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/29/2015
• Event Location: Hospital
• Date Report to Manufacturer: 09/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 48 YR