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

Lot Number 125C44

Device Problem Material Rupture (1546)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/20/2023

Event Type  malfunction  

Event Description

During laparoscopic appendectomy, surgeon is prepared to remove specimen from body, attempts to use endopouch retriever and bag rips, dropping specimen back into body.A second identical endopouch is opened to the field and surgeon attempts to use.That bag also rips in the same way.Surgeon requests retrieval bag from a different manufacturer.A conmed anchor bag is opened to the field and used successfully.No other issues.Reference report #mw5115563.

• Brand Name: ENDOPOUCH RETRIEVER
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, INC.
• MDR Report Key: 16512437
• MDR Text Key: 311045480
• Report Number: MW5115564
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 03/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 125C44
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Sex: Female