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

Model Number 176625

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 08/11/2021

Event Type  malfunction  

Event Description

Patient scheduled for lap cholecystectomy.The laparoscopic clip applier malfunctioned.It was inserted in the abdominal cavity but surgeon did not apply the clip as it did not work.Another clip applier had to be opened and was used.

• Brand Name: ENDO CLIP
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 12432274
• MDR Text Key: 270167534
• Report Number: 12432274
• 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: 09/02/2021,08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 176625
• Device Catalogue Number: 176625
• Device Lot Number: J1B1416NY
• 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: 09/02/2021
• Date Report to Manufacturer: 09/07/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 17885 DA