MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC LIGACLIP; CLIP, IMPLANTABLE

Model Number ER320

Device Problems Difficult to Open or Close (2921); Output Problem (3005)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 07/28/2021

Event Type  malfunction  

Event Description

Ligaclip 10-m/l 10mm endoscopic rotating open-surgery ligation clip applier did not work during surgical procedure.The ligaclip fired off but did not compress at all, stayed completely open, meaning the bleeding was not stopped.A second ligaclip applier was opened with the same lot number and it worked.

• Brand Name: LIGACLIP
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 00969
• MDR Report Key: 12438374
• MDR Text Key: 270301116
• Report Number: 12438374
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ER320
• Device Catalogue Number: ER320
• Device Lot Number: 251A42
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/24/2021
• Event Location: Hospital
• Date Report to Manufacturer: 09/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 19710 DA
• Patient Weight: 58