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

Model Number 176657

Device Problem Misfire (2532)

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

Event Date 02/15/2022

Event Type  malfunction  

Event Description

A endo clip¿ ii 10 mm clip applier misfired, another device obtained and procedure continued as expected with no further incidents or harm to the patient.The endo clip¿ ii 10 mm clip applier that misfired was discarded by staff in error.

• Brand Name: ENDO CLIP II
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP; 60 middletown ave.; north haven CT 06473
• MDR Report Key: 15040901
• MDR Text Key: 296068242
• Report Number: 15040901
• 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: 04/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 176657
• Device Catalogue Number: 176657
• Device Lot Number: J1F1607NY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/15/2022
• Date Report to Manufacturer: 07/18/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25185 DA