MAUDE Adverse Event Report: TELEFLEX MEDICAL WECK HORIZON LIGATING CLIP APPLIER; APPLIER, SURGICAL, CLIP

Model Number	IPN914955
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
While clipping a blood vessel, after closing the clip, the clip got stuck to the applier.The patient's condition was reported as fine.
Event or Problem Description
While clipping a blood vessel, after closing the clip, the clip got stuck to the applier.The patient's condition was reported as fine.
Additional Manufacturer Narrative
(b)(4).The dhr for the late returned instrument was reviewed and found completely without any irregularities.This instrument was produced at the aesculap facility in germany and inspected and processed to teleflex print specifications at the tecomet inc.Kenosha wi facility as part of a (b)(4)-piece lot in july of 2021.Evaluation of the returned instrument shows that it is able to pick-up, retain, close and release multiple clips with or without the use of silastic test tubing without any clips sticking to the jaws as described in the submitted notification summary.There were no non-conforming features found on the returned device.We are unable to validate this complaint since we are unable to replicate the alleged issue.All (b)(4)instruments from this lot were 100% visually inspected and function tested prior to shipment to the customer as this is a standardized procedure at this facility for this product line.Due to these findings, no further actions will be taken in response to this complaint and this record will be deemed closed.

• Brand Name: WECK HORIZON LIGATING CLIP APPLIER
• Common Device Name: APPLIER, SURGICAL, CLIP
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 12531971
• Report Number: 3011137372-2021-00242
• Device Sequence Number: 16484190
• Product Code: GDO
• UDI-Device Identifier: 24026704710038
• UDI-Public: 24026704710038
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2021

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: IPN914955
• Device Catalogue Number: 237081
• Device Lot Number: 12345
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2021
• Supplement Date Received by Manufacturer: 11/17/2021
• Initial Report FDA Received Date: 09/27/2021
• Supplement Report FDA Received Date: 11/19/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown