MAUDE Adverse Event Report: TELEFLEX MEDICAL HZ APPLIER LG 11" CVD; APPLIER, SURGICAL, CLIP

Model Number	IPN914994
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2023
Type of Reportable Event	Malfunction
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
Reported issue: horizon large size open appliers failed to release clips after being closed onto the vessel.There was no patient injury.
Additional Manufacturer Narrative
(b)(4).Additional information received indicates the event was not reportable; therefore, the initial mdr submitted on 04 april 2023 should be retracted.
Event or Problem Description
Reported issue: horizon large size open appliers failed to release clips after being closed onto the vessel.There was no patient injury.

• Brand Name: HZ APPLIER LG 11" 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: marling heaton ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 16676170
• Report Number: 3011137372-2023-00095
• Device Sequence Number: 6539833
• Product Code: GDO
• UDI-Device Identifier: 24026704710243
• UDI-Public: 24026704710243
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2023

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: IPN914994
• Device Catalogue Number: 437111
• Device Lot Number: 06E1751201
• 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: 03/30/2023
• Supplement Date Received by Manufacturer: 03/30/2023
• Initial Report FDA Received Date: 04/04/2023
• Supplement Report FDA Received Date: 05/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2018
• 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
• Patient Sex: Unknown