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

Model Number 176620

Device Problems Difficult to Open or Close (2921); Device Dislodged or Dislocated (2923); Activation Failure (3270)

Patient Problem Insufficient Information (4580)

Event Date 10/15/2021

Event Type  malfunction  

Event Description

Endo clip 5 mm single use clip applier did not deploy nor secure clips for ligation of vessel during laparoscopic cholecystectomy.Multiple clips were applied to the vessel and each one popped off and didn't close correctly on the vessel.The provider chose to use an alternative form of ligation.

• Brand Name: ENDO CLIP
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 12915163
• MDR Text Key: 281595990
• Report Number: 12915163
• 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: 11/17/2021

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: 176620
• Device Catalogue Number: 176620
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/17/2021
• Event Location: Hospital
• Date Report to Manufacturer: 12/02/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 12775 DA
• Patient Sex: Female