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

Catalog Number POUCH

Device Problem Difficult to Open or Close (2921)

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

Event Date 01/27/2015

Event Type  malfunction  

Event Description

The endopouch was used in normal fashion and failed to close to retrieve the specimen; another pouch was opened to complete the procedure.Manufacturer response for endopouch, (brand not provided) (per site reporter).
=
issued rga# and sent return kit.

• Brand Name: ENDOPOUCH
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, INC.; 4545 creek road; cincinnati OH 45242
• MDR Report Key: 4598372
• MDR Text Key: 5700457
• Report Number: 4598372
• Device Sequence Number: 1
• Product Code: GCJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 03/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Unknown
• Device Catalogue Number: POUCH
• Device Lot Number: L4FD8Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2015
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/09/2015
• Event Location: Hospital
• Date Report to Manufacturer: 03/13/2015
• Patient Sequence Number: 1
• Patient Age: 23 YR