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

Model Number	IPN914939
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).The device has not been returned for investigation.
Event or Problem Description
Past 6 months surgeons have noticed, that clips are not holding tight and drop to surgical site from applier and it always applier repaired 137082, other size of appliers working perfect.No injury reported.
Event or Problem Description
Past 6 months surgeons have noticed, that clips are not holding tight and drop to surgical site from applier and it always applier repaired 137082, other size of appliers working perfect.No injury reported.
Additional Manufacturer Narrative
(b)(4), device history record was reviewed for notifications pertaining to incoming inspection, stock checks, and product returns.No concerns were noted with reference to 137082.(1) sample of 137082 was received for evaluation with lot #336478.This lot # predates 2006 lot number format and is over 10 years old.The device is also etched with a repair date of 11-21 (nov 2021) documenting the last time it was serviced and calibrated.The complaint describes clips falling out of the jaws prior to application over a 6-month period of time.The referenced repair date exceeds the recommended service interval.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.Functionality is critical to proper holding methods.Devices should be serviced when operational difficulties are initially observed and the device in question is over 10 years old which exceeds expected life.Despite the age of the device , it still functions correctly.(1) sample of 137082 was received for evaluation with lot #336478.This lot # predates 2006 lot number format and is over 10 years old.The device is also etched with a repair date of 11-21 (nov 2021) documenting the last time it was serviced and calibrated.The complaint describes clips falling out of the jaws prior to application over a 6-month period of time.The referenced repair date exceeds the recommended service interval.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.Device is over 10 years old and has exceeded expected life.Complaint history not applicable.Device history record was reviewed for notifications pertaining to incoming inspection, stock checks, and product returns.No concerns were noted with reference to 137082.Functionality is critical to proper holding methods.Devices should be serviced when operational difficulties are initially observed and the device in question is over 10 years old which exceeds expected life.Despite the age of the device , it still functions correctly.

• 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: 14982627
• Report Number: 3011137372-2022-00126
• Device Sequence Number: 20108300
• 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): 06/29/2022

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: UNKNOWN
• 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: 06/29/2022
• Supplement Date Received by Manufacturer: 09/02/2022
• Initial Report FDA Received Date: 07/11/2022
• Supplement Report FDA Received Date: 09/06/2022
• 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