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

Model Number	IPN914939
Medical Device Problem Code	Mechanics Altered (2984)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
We got the feedback from horizon applier item number 137082, what customer has used decades.Helsinki university hospital is the client.They are using always with horizon clips with horizon applier.They have used also always your maintenance service, when they got new repaired appliers, when they send back to repair used appliers to you.Past 6 months surgeons have noticed that clips are not hold tight and drop to surgical site from applier and it always applier repaired 137082, other size of appliers working perfect.
Additional Manufacturer Narrative
Qn# (b)(4).The device investigation is pending.
Additional Manufacturer Narrative
(b)(4).One sample of 137082 lot# 04c0800032 was returned for evaluation.This device is over 10 years old and has exceeded the expected life.The device was confirmed to pick-up and hold clips.This appears to be a usage error and may be noticed more in older appliers due to spring wear.Clips will drop if handles are partially closed which deforms the clips prior to application.The small clip is the most fragile of the clips.Age of device is more than 10 years old and beyond expected life.Device history record was reviewed for notifications pertaining to incoming inspection, stock checks, and product returns.No concerns were noted.The manufacturer will continue to monitor and trend for reports of this nature.
Event or Problem Description
We got the feedback from horizon applier item number 137082, what customer has used decades.(b)(6) hospital is the client.They are using always with horizon clips with horizon applier.They have used also always your maintenance service, when they got new repaired appliers, when they send back to repair used appliers to you.Past 6 months surgeons have noticed that clips are not hold tight and drop to surgical site from applier and it always applier repaired 137082, other size of appliers working perfect.

• Brand Name: HZ APPLIER SMALL WIDE 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: 15277976
• Report Number: 3011137372-2022-00171
• Device Sequence Number: 6956119
• Product Code: GDO
• UDI-Device Identifier: 24026704709957
• UDI-Public: 24026704709957
• 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): 08/11/2022

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: IPN914939
• Device Catalogue Number: 137082
• Device Lot Number: 04C0800032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2022
• Supplement Date Received by Manufacturer: 10/10/2022
• Initial Report FDA Received Date: 08/23/2022
• Supplement Report FDA Received Date: 10/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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.
• Patient Sex: Unknown