MAUDE Adverse Event Report: TELEFLEX MEDICAL WECK; INSTRUMENT, LIGATURE PASSING AND KNOT TYING

Model Number	IPN917216
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
When the device was deployed, the team heard a snap.They examined the device and the side part has broken off.Another similar device was used and the procedure was completed without any further incident.Manufacturer response for instrument, ligature passing and knot tying, weck (per site reporter).Robotic coordinator spoke to field representative.

• Brand Name: WECK
• Common Device Name: INSTRUMENT, LIGATURE PASSING AND KNOT TYING
• Manufacturer (Section D): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• MDR Report Key: 20395912
• Report Number: 20395912
• Device Sequence Number: 8037754
• Product Code: HCF
• UDI-Device Identifier: 14026704736321
• UDI-Public: (01)14026704736321(17)260912(11)230912(10)3402970000
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/26/2024
• Report Date (Section F): 07/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: IPN917216
• Device Catalogue Number: EFX002
• Device Lot Number: 3402970000
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/08/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/08/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Weight: 90 KG
• Date Report Sent to FDA: 07/03/2024