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

Model Number	IPN008965
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	12/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device investigation is pending.
Event or Problem Description
When closing vessel with microclip vessel is cut.
Event or Problem Description
When closing vessel with microclip vessel is cut.
Additional Manufacturer Narrative
(b)(4).The dhr for the returned instrument was reviewed and found completely without any irregularities.This instrument was produced at the tecomet, inc.Kenosha wi facility as part of a (b)(4)-piece lot in may of 2018.It was found that this order was made from the correct materials and components and all approved processes were followed so it can then be stated that the alleged non-conformance inciting this complaint was not due to an error in tecomet - kenosha's manufacturing process.Evaluation of the returned instrument shows that the jaws are slightly misaligned with each other in the closed position.(pie's attached) functional evaluation shows that although the tips are slightly misaligned to each other in the closed position this instrument is able to pick-up, retain, close and release multiple clips without any problems.We are unable to determine what caused the tips to be slightly misaligned with each other in the closed position but mishandling of this device at the end user's facility is suspected.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: 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: 14455318
• Report Number: 3011137372-2022-00081
• Device Sequence Number: 15057229
• Product Code: GDO
• UDI-Device Identifier: 24026704696639
• UDI-Public: 24026704696639
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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
• Report Date (Section B): 04/25/2022

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: IPN008965
• Device Catalogue Number: 537081
• Device Lot Number: 06J1757100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2022
• Supplement Date Received by Manufacturer: 06/17/2022
• Initial Report FDA Received Date: 05/20/2022
• Supplement Report FDA Received Date: 06/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/16/2018
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown