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

Model Number	IPN008965
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	11/29/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
A surgeon had issues with our 537081 appliers.They damaged the vessels.
Additional Manufacturer Narrative
Qn# (b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
A surgeon had issues with our 537081 appliers.They dammage the vessels.
Additional Manufacturer Narrative
Qn#(b)(4).Per customer provided information this instrument was not produced at this facility.Based on lot information provided we believe this instrument was produced at the teleflex rtp facility.This instrument has not been returned for review or evaluation therefore we are unable to determine what may have caused the alleged defect or validate the alleged complaint.All instruments of this type which are produced at this facility are 100% visually inspected and function tested prior to release 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
A surgeon had issues with our 537081 appliers.They dammage the vessels.
Additional Manufacturer Narrative
(b)(4).Device history record was reviewed for notifications pertaining to incoming inspection, stock checks, and product returns.No concerns were noted with reference to 537081.Isolated incident.The referenced device lot was distributed over 10 years ago.This instrument applies a ligating clip with parallel closure.This device requires routine service for optimal performance.The only opportunity for vessel damage is misaligned jaws resulting from lack of service, physical damage, or improper use of the applier.A review of the actual product involved in the complaint could not be conducted since the product was not returned.Device history record was reviewed for notifications pertaining to incoming inspection, stock checks, and product returns.No concerns were noted with reference to (b)(4).Isolated incident.The referenced device lot was distributed over 10 years ago.This instrument applies a ligating clip with parallel closure.This device requires routine service for optimal performance.The only opportunity for vessel damage is misaligned jaws resulting from lack of service, physical damage, or improper use of the applier.

• Brand Name: HZ APPLIER MICRO 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: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 12961547
• Report Number: 3011137372-2021-00339
• Device Sequence Number: 5449318
• Product Code: GDO
• UDI-Device Identifier: 24026704696639
• UDI-Public: 24026704696639
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: IPN008965
• Device Catalogue Number: 537081
• Device Lot Number: 2007634-080
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2021
• Supplement Date Received by Manufacturer: 01/24/2022; 02/23/2022
• Initial Report FDA Received Date: 12/08/2021
• Supplement Report FDA Received Date: 01/25/2022; 02/28/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.
• Patient Sex: Unknown