MAUDE Adverse Event Report: TELEFLEX MEDICAL HZ APPLIER SMALL 8" CVD; APPLIER, SURGICAL, CLIP

Model Number	IPN003133
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that during a triple coronary artery bypass graft between anterior interventricular artery, when attempting to remove the left internal mammary artery, the jaws of the applier misaligned and "altered the artery".The misalignment occurred on the first clip of the applier.Additional information states, "the surgeon simply specified that the artery was damaged, without further details.In total for this intervention we recovered 5 pliers, 2 from lot 06d1517606 (lot associated with the injured artery), 1 from lot 562472-029, 1 from lot 316340 and 1 from lot 06c1400093.According to the surgeon, none of the forceps gave satisfaction, with crossing jaws." further information states that "there were no consequences for the patient and [the doctor] continued the triple coronary artery bypass surgery".The patient status is reported as "fine".
Event or Problem Description
It was reported that during a triple coronary artery bypass graft between anterior interventricular artery, when attempting to remove the left internal mammary artery, the jaws of the applier misaligned and "altered the artery".The misalignment occurred on the first clip of the applier.Additional information states, "the surgeon simply specified that the artery was damaged, without further details.In total for this intervention we recovered 5 pliers, 2 from lot 06d1517606 (lot associated with the injured artery), 1 from lot 562472-029, 1 from lot 316340 and 1 from lot 06c1400093.According to the surgeon, none of the forceps gave satisfaction, with crossing jaws." further information states that "there were no consequences for the patient and [the doctor] continued the triple coronary artery bypass surgery".The patient status is reported as "fine".
Additional Manufacturer Narrative
Qn#(b)(4).One sample of 137081 lot#316340 was received for evaluation.No visual concerns were noted with the sample.The device functions as expected unless excessive pressure is applied to the handles which results in lateral movement of the jaws due to wear in the boxlock region.The service date on the device is greater than 1 year old and the manufacturing lot is over 15 years old.The sample provided has exceeded the life expectancy for this product.

• Brand Name: HZ APPLIER SMALL 8" CVD
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 16947234
• Report Number: 3003898360-2023-00782
• Device Sequence Number: 16707318
• Product Code: GDO
• UDI-Device Identifier: 34026704622611
• UDI-Public: 34026704622611
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2023

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: IPN003133
• Device Catalogue Number: 137081
• Device Lot Number: 316340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2023
• Supplement Date Received by Manufacturer: 08/11/2023
• Initial Report FDA Received Date: 05/17/2023
• Supplement Report FDA Received Date: 08/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Male