MAUDE Adverse Event Report: COVIDIEN ENDO CLIP II; CLIP APPLIER

Catalog Number 176657

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/09/2019

Event Type  malfunction  

Event Description

The clip applier malfunctioned; it would not work as it was supposed too.It would not deploy the clip when the handle was squeezed.A second clip applier was obtained which worked correctly.

• Brand Name: ENDO CLIP II
• Type of Device: CLIP APPLIER
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 8365841
• MDR Text Key: 137018735
• Report Number: 8365841
• Device Sequence Number: 1
• Product Code: GDO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 176657
• Device Lot Number: J8F2148NX
• 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: 02/13/2019
• Event Location: Hospital
• Date Report to Manufacturer: 02/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 27010 DA
• Patient Weight: 80