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
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) n/a.Other remarks: n/a.Corrected data: n/a.
Additional Manufacturer Narrative
Qn# (b)(4).The sample was returned and sent to the manufacturing site (tecomet) for investigation.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 99-pc.Lot in february of 2016.Evaluation of the returned instrument shows that it has additional lot coding of (r-08-19) on the stem of the single handle, which signifies that this instrument was sent in for repair servicing prior to this complaint.Functional testing shows that this instrument is able to pick-up, retain, closed and release multiple clips with no issues found.Further evaluation shows that the jaws are aligned properly in the open and closed positions therefore we are unable to validate this complaint for the returned instrument.All 99 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.".
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".

• 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: 16945522
• Report Number: 3003898360-2023-00780
• Device Sequence Number: 2161827
• 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: 06C1400093
• 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: 09/20/2023
• Initial Report FDA Received Date: 05/17/2023
• Supplement Report FDA Received Date: 09/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2016
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.
• Patient Age: 65 YR
• Patient Sex: Male