MAUDE Adverse Event Report: COVIDIEN LP PREMIUM SURGICLIP II CLIP APPLIER; CLIP, IMPLANTABLE

Model Number 134051

Device Problem Misfire (2532)

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

Event Date 02/17/2021

Event Type  malfunction  

Event Description

The clip applier misfired multiple times during procedure and was unusable.Clip applier was replaced with a new one.No adverse outcomes for the patient because of this failure.The representative was notified of the event.

• Brand Name: PREMIUM SURGICLIP II CLIP APPLIER
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11371848
• MDR Text Key: 233261522
• Report Number: 11371848
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 02/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 134051
• Device Catalogue Number: 134051
• Device Lot Number: P0K0381Y
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/18/2021
• Event Location: Hospital
• Date Report to Manufacturer: 02/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 20440 DA