MAUDE Adverse Event Report: COVIDIEN ENDO CLIP APPLIER 5MM; APPLIER, SURGICAL, CLIP

Lot Number J9B1793Y

Device Problem Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 08/13/2019

Event Type  malfunction  

Event Description

Endo clip applier malfunctioned.There could be a possibility of a retained foreign object.Per surgeon, this has happened multiple times with this clip applier.

• Brand Name: ENDO CLIP APPLIER 5MM
• Type of Device: APPLIER, SURGICAL, CLIP
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 9076100
• MDR Text Key: 159120098
• Report Number: MW5089835
• Device Sequence Number: 1
• Product Code: GDO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: J9B1793Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 127