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

Model Number IPN008965

Device Problem Positioning Problem (3009)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 12/01/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device investigation is pending.

Event Description

When closing vessel with microclip vessel is cut.

Event Description

When closing vessel with microclip vessel is cut.

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 aligned with each other in the closed position and no non-conforming features were found.Functional testing shows that this instrument is able to pick-up, retain, close and release multiple clips without any issues.We are unable to replicate the alleged issue therefore we are unable to validate this complaint.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
• Type of Device: 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: 14455162
• MDR Text Key: 292168550
• Report Number: 3011137372-2022-00080
• Device Sequence Number: 1
• Product Code: GDO
• UDI-Device Identifier: 24026704696639
• UDI-Public: 24026704696639
• Combination Product (y/n): N
• Reporter Country Code: FI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 06/17/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/16/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other