MAUDE Adverse Event Report: TELEFLEX MEDICAL HOR ENDO CLIP APPLIER MED-LG; APPLIER, SURGICAL, CLIP

Catalog Number	338110
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
The report states "the endo applier is missing the screw, and they cannot say where it has gone.Could be in the patient, or on the floor.I asked if it could have occurred during cleaning, prior to surgery, unfortunately they have no certainty when this happened at the moment".At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.
Additional Manufacturer Narrative
(b)(4).Additional information received on 01 dec 2023 states the customer "cannot find exactly in which case this is happen, even if it happened during the cleaning process".No imaging was performed as " this is used in laparoscopy case, if we lost it, it will happen outside the wound and the only way the screw can go is the floor.On my actual knowledge no patient is involved".The reported complaint of loose parts - pin falling was confirmed upon the investigation of the returned sample.Evaluation of the returned device showed that the shoulder screw that holds the proximal and distal handles together was missing from the returned instrument.The instrument was returned with a non-teleflex luer flush port cap.Functional evaluation of this instrument was performed, and it was found that although the jaws were slightly loose and misaligned this instrument was able to pick-up, retain, close, and release multiple clips as required of its function despite missing of the handle pivot screw.It could not be conclusively determined what caused what caused the shoulder pivot screw to become loose and missing from the returned instrument but lack of proper maintenance at the end user's facility, as per the ifu along with the product, is suspected.The device history record for the returned instrument was reviewed and was found without any irregularities.All 24 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.Teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
The report states "the endo applier is missing the screw, and they cannot say where it has gone.Could be in the patient, or on the floor.I asked if it could have occurred during cleaning, prior to surgery, unfortunately they have no certainty when this happened at the moment".At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.

• Brand Name: HOR ENDO CLIP APPLIER MED-LG
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 18222254
• Report Number: 3011137372-2023-00254
• Device Sequence Number: 5788425
• Product Code: GDO
• UDI-Device Identifier: 24026704428872
• UDI-Public: 24026704428872
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2023

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 Catalogue Number: 338110
• Device Lot Number: 06B1866160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2023
• Supplement Date Received by Manufacturer: 12/19/2023
• Initial Report FDA Received Date: 11/28/2023
• Supplement Report FDA Received Date: 12/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown