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

Model Number 176630

Device Problem Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/18/2022

Event Type  malfunction  

Event Description

5mm covidien endo clip applier ref 176630, jammed intra op, no clip applied upon use, surgeon removed applier for test outside patient body, applier remained in the closed position.

• Brand Name: ENDO CLIP III
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 15437164
• MDR Text Key: 300044663
• Report Number: 15437164
• 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: 09/07/2022,09/06/2022

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 Model Number: 176630
• Device Catalogue Number: 176630
• Device Lot Number: J1M1737Y
• 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: 09/07/2022
• Date Report to Manufacturer: 09/16/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/16/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 8030 DA
• Patient Sex: Female