MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, INC. ENDOSCOPIC MULTIPLE CLIP APPLIER; CLIP, IMPLANTABLE

Device Problems Failure to Form Staple (2579); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 06/24/2022

Event Type  malfunction  

Event Description

Three separate 5mm disposable laparoscopic staplers failed during procedure (1 included in this medwatch.) stapler would not properly eject staple or properly close staple, 4 staplers were opened until one was found to function correctly.Fda safety report id # (b)(4).

• Brand Name: ENDOSCOPIC MULTIPLE CLIP APPLIER
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, INC.; somerville CO 08876
• MDR Report Key: 15043356
• MDR Text Key: 296140558
• Report Number: MW5110914
• Device Sequence Number: 3
• Product Code: FZP
• 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: 07/13/2022
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Sex: Male