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

Model Number	IPN914937
Medical Device Problem Code	Dent in Material (2526)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The part of the pivot pin was found dented upon opening the package.Therefore, a new unit was used instead.
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
The part of the pivot pin was found dented upon opening the package.Therefore, a new unit was used instead.
Additional Manufacturer Narrative
(b)(4).The dhr for the returned device 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 january of 2020.Visual evaluation of the returned instrument shows that the rivet that holds the single and double stems together in the box appears to have become un-staked from its original position and appear as dented thus we are able to validate this complaint.Functional evaluation shows that the rivet does not move or rotate when the device is used to pick-up, retain, close and release a clip and remains staked in its current position thus it is not loose to be spinning freely or potentially fall out of the instrument.We are unable to determine what caused the rivet to become un-staked from its original position and appear as dented 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 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: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 13444671
• Report Number: 3011137372-2022-00021
• Device Sequence Number: 13964436
• Product Code: GDO
• UDI-Device Identifier: 24026704709940
• UDI-Public: 24026704709940
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 01/25/2022

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: IPN914937
• Device Catalogue Number: 137081
• Device Lot Number: 06C1985539
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2022
• Supplement Date Received by Manufacturer: 03/17/2022
• Initial Report FDA Received Date: 02/03/2022
• Supplement Report FDA Received Date: 03/19/2022
• 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
• Patient Sex: Unknown