MAUDE Adverse Event Report: COVIDIEN LP ENDO CLIP III; CLIP, IMPLANTABLE

Model Number 176630

Device Problem Misfire (2532)

Patient Problem Insufficient Information (4580)

Event Date 11/01/2022

Event Type  malfunction  

Event Description

Covidien endoclip applier misfiring during laparoscopic cholecystectomy and liver biopsy surgical case.Endoclip crossing over each other.Manufacturer response for clip, implantable, endo clip iii (per site reporter).

• Brand Name: ENDO CLIP III
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 16929570
• MDR Text Key: 315187735
• Report Number: 16929570
• 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: Nurse
• Type of Report: Initial
• Report Date: 05/09/2023,12/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 176630
• Device Catalogue Number: 176630
• Device Lot Number: J2J0501Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/09/2023
• Event Location: Hospital
• Date Report to Manufacturer: 05/15/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 16425 DA
• Patient Sex: Female
• Patient Weight: 57 KG
• Patient Ethnicity: Hispanic