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

Model Number ER420

Device Problem Misfire (2532)

Patient Problem Insufficient Information (4580)

Event Date 05/26/2021

Event Type  malfunction  

Event Description

Ligaclip® endoscopic rotating multiple clip applier misfired multiple times when stapling the common bile duct and artery.The failed staples were removed from the patient and a new ligaclip® endoscopic clip applier was opened and used.The malfunctioning clip applier was er420 with lot #v9469n.The malfunction device was wiped down, placed back in the original box and given to the charge nurse.

• Brand Name: LIGACLIP
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 00969
• MDR Report Key: 11974043
• MDR Text Key: 255359143
• Report Number: 11974043
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10705036012597
• UDI-Public: (01)10705036012597
• 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: 06/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ER420
• Device Catalogue Number: ER420
• Device Lot Number: V9469N
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/02/2021
• Event Location: Hospital
• Date Report to Manufacturer: 06/10/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 10585 DA