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
Qn# (b)(4).
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." the patient status is reported as "fine".
Additional Manufacturer Narrative
Qn #: (b)(4).Additional information received on 17 may 2023 states that "there were no consequences for the patient and [the doctor] continued the triple coronary artery bypass surgery".The sample was returned and sent to the manufacturer (tecomet) for evaluation.Tecomet reports "the dhr for the returned instrument was reviewed and found complete without any irregularities.This instrument was produced at the tecomet, inc.Kenosha, wi facility as part of a 100-pc.Lot in june of 2016.It was found that this order was made from the correct materials and components and all approved processes were followed.Evaluation of the returned instrument as received shows that the jaws are slightly misaligned in the closed position.We are able to validate this complaint for the returned instrument.We are unable to determine what caused the jaws to be slightly misaligned in the closed position but mishandling of the returned device at the end user's facility is suspected.All 100 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." 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." the patient status is reported as "fine".

• 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: 16942679
• Report Number: 3011137372-2023-00133
• Device Sequence Number: 16979183
• 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): 04/25/2023

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 Expiration Date: 01/28/2022
• Device Model Number: IPN003133
• Device Catalogue Number: 137081
• Device Lot Number: 06D1517606
• 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: 04/25/2023
• Supplement Date Received by Manufacturer: 07/17/2023
• Initial Report FDA Received Date: 05/16/2023
• Supplement Report FDA Received Date: 07/17/2023
• 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