MAUDE Adverse Event Report: TELEFLEX MEDICAL TELEFLEX MEDIUM - LARGE NON-ABSORBABLE POLYMER LIGATION CLIP; CLIP, IMPLANTABLE

Model Number 51114V

Device Problem Break (1069)

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

Event Date 10/13/2022

Event Type  malfunction  

Event Description

The ligation clip used during a robotic cholecystectomy broken in half during procedure, one piece located the other half was not.Fda safety report id #(b)(4).

• Brand Name: TELEFLEX MEDIUM - LARGE NON-ABSORBABLE POLYMER LIGATION CLIP
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC 27560
• MDR Report Key: 15716129
• MDR Text Key: 302967838
• Report Number: MW5113035
• Device Sequence Number: 1
• Product Code: FZP
• 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: 10/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 51114V
• Device Lot Number: 228029
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 31 YR
• Patient Sex: Male
• Patient Weight: 87 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White