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

Model Number	IPN915190
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The tip of the applier was bent it was used in upper gi case.They noticed the tip bent at the end of the procedure.The patient was fine the applier worked fine through the procedure.
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.
Event or Problem Description
The tip of the applier was bent it was used in upper gi case.They noticed the tip bent at the end of the procedure.The patient was fine the applier worked fine through the procedure.
Additional Manufacturer Narrative
Qn# (b)(4).The dhr for the returned instrument was reviewed and found completely without any irregularities.This instrument was produced at the tecomet, inc.Kenosha wi facility as part of a 25-piece lot in july of 2018.Evaluation of the returned instrument shows that as received the luer flush port cap is missing and the jaws are loose and misaligned and bent to the left and the jaw pivot pin is pulled thru one side of the damaged/bent outer tube assembly.We are able to validate this complaint.After the initial evaluation this instrument was dis-assembled in order to evaluate its internal components and it was found that the inner drive rod (b)(6) is bent, and its bosses are both damaged where they engage the jaws.We suspect that the damaged drive rod bosses caused the jaws to become slightly loose and misaligned in the closed position.We are unable to determine what caused the drive rod to become bent and for its bosses to become damaged and for the outer tube assembly to become bent/damaged but mishandling of this device at the end user's facility is suspected.All 25 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.

• 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: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 14852861
• Report Number: 3011137372-2022-00121
• Device Sequence Number: 5310322
• Product Code: GDO
• UDI-Device Identifier: 24026704697834
• UDI-Public: 24026704697834
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 06/20/2022

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: IPN915190
• Device Catalogue Number: 544965L
• Device Lot Number: 06A1863136
• 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: 06/20/2022
• Supplement Date Received by Manufacturer: 08/15/2022
• Initial Report FDA Received Date: 06/29/2022
• Supplement Report FDA Received Date: 08/15/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.
• Patient Sex: Unknown