MAUDE Adverse Event Report: TELEFLEX MEDICAL HOL ML ENDO APPLIER 5MM 45CM; APPLIER, SURGICAL, CLIP

Model Number	IPN915190
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device investigation is pending.A follow-up report will be submitted when it is completed.
Event or Problem Description
Reported issue: clips broke when they were trying to load them.No reported injury.
Additional Manufacturer Narrative
Qn# (b)(4).The dhr for the returned instrument was reviewed and found complete without any irregularities.This instrument was produced at the tecomet, inc.Kenosha, wi facility as part of a 50-pc.Lot in may of 2020.It was found that this order was made from the correct materials and components and all approved processes were followed.It can then be stated that the alleged non-conformance inciting this complaint was not due to an error in tecomet -kenosha's manufacturing process.Evaluation of the returned instrument as received shows that it is missing its luer port cap and that it must have been sent in for repair previous to this complaint since it has repair lot coding of r-08-22 laser marked on the side of the proximal handle (g00436m).Further evaluation shows that one of the jaws is bent damaged and is making the closed tip set gap of (.008" +.004/-.007) measure oversized at.070" and not allowing the instrument to fully close a clip during functional testing.We are able to validate this complaint.We are unable to determine what caused one of the jaws to be bent/damaged and for the closed tip set gap to be over-sized after this instrument was repaired but mishandling of this device at the end user's facility is suspected.All 50 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.
Event or Problem Description
Reported issue: clips broke when they were trying to load them.No reported injury.

• Brand Name: HOL ML ENDO APPLIER 5MM 45CM
• 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 16525030
• Report Number: 3011137372-2023-00044
• Device Sequence Number: 6458426
• Product Code: GDO
• UDI-Device Identifier: 24026704697834
• UDI-Public: 24026704697834
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: IPN915190
• Device Catalogue Number: 544965L
• Device Lot Number: 06C1985982
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2023
• Supplement Date Received by Manufacturer: 04/06/2023
• Initial Report FDA Received Date: 03/10/2023
• Supplement Report FDA Received Date: 04/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2019
• 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: NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown