MAUDE Adverse Event Report: TELEFLEX MEDICAL HOR TAP ENDO CLIP APPLIER M/L; APPLIER, SURGICAL, CLIP

Model Number	IPN914988
Medical Device Problem Codes	Break (1069); Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2021
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
Please note that the applier tip is loose not fixed with the shaft, so when you press the handle the jaws move forward then generate pressure to the clip, which cause inconvenience while using and the jaws are misaligned.It is reported that: during surgery it started to loosen the tip from shaft which makes it difficult and inconvenient to work with.Regarding the sterilization kindly note that the product is usually sterilized around 3 times a day with chemical sterilization (cold sterilization) sterilization record card is not available.
Additional Manufacturer Narrative
(b)(4).Upon review of the device history records for the affected lot number, we can confirm that both the correct material and correct components had been used and that the instrument meets the product specifications.All process steps were found to have been properly documented.100% functional test at final inspection found good.The instrument was received by the supplier.It was determined that the instrument was poorly maintained (wear and tear).There is nothing to add to the report, the instrument is in a very bad condition and completely worn out.No further measures will be initiated.
Event or Problem Description
Please note that the applier tip is loose not fixed with the shaft, so when you press the handle the jaws move forward then generate pressure to the clip, which cause inconvenience while using and the jaws are misaligned.It is reported that: during surgery it started to loosen the tip from shaft which makes it difficult and inconvenient to work with.Regarding the sterilization kindly note that the product is usually sterilized around 3 times a day with chemical sterilization (cold sterilization) sterilization record card is not available.

• Brand Name: HOR TAP ENDO CLIP APPLIER M/L
• 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: 12656039
• Report Number: 3011137372-2021-00286
• Device Sequence Number: 1207697
• Product Code: GDO
• UDI-Device Identifier: 24026704697100
• UDI-Public: 24026704697100
• Combination Product (Y/N): N
• Initial Reporter Country: JO
• 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): 10/04/2021

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: IPN914988
• Device Catalogue Number: 338110T
• Device Lot Number: F8-02
• 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: 10/04/2021
• Supplement Date Received by Manufacturer: 03/15/2022
• Initial Report FDA Received Date: 10/19/2021
• 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