MAUDE Adverse Event Report: TELEFLEX MEDICAL HOL L 10MM ENDO APPLIER; APPLIER, SURGICAL, CLIP

Catalog Number	544995
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use on a patient, the applier jaws were misaligned.As a result, a new applier was used to complete the procedure.No patient harm or injury, no clips/parts fell into patient.The patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The reported complaint of applier jaws - misaligned could not be confirmed due the product sample was not available to perform a proper investigation.Dhr investigation did not show issues related to complaint.Without the device to evaluate, the probable root cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that during use on a patient, the applier jaws were misaligned.As a result, a new applier was used to complete the procedure.No patient harm or injury, no clips/parts fell into patient.The patient status is reported as "fine".
Additional Manufacturer Narrative
Qn#(b)(4).The sample was returned to the manufacturer for investigation.The manufacturer, tecomet, reported:" the dhr for the returned instrument was reviewed and found complete without any irregularities.This instrument was produced at the tecomet, kenosha, wi facility as part of a 50-pc.Lot in june of 2022.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 device shows that the jaws are slightly misaligned to each other in the closed position.Functional evaluation of the returned device shows that although the jaws are slightly misaligned in the closed position that it is able to pick-up, retain, close and release multiple clips both with and without the use of silastic test tubing.We are able to validate this complaint for the returned instrument.We are unable to determine what caused the jaws to be slightly misaligned in the closed position but mishandling of the returned 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." teleflex will continue to monitor and trend on complaints of this nature.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that during use on a patient, the applier jaws were misaligned.As a result, a new applier was used to complete the procedure.No patient harm or injury, no clips/parts fell into patient.The patient status is reported as "fine".
Event or Problem Description
It was reported that during use on a patient, the applier jaws were misaligned.As a result, a new applier was used to complete the procedure.No patient harm or injury, no clips/parts fell into patient.The patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.The customer submitted video revealed the device being used in a surgery and a clip being applied, but the clip was not fully engaged into one of the jaws of the applier thus creating a misload condition and when released the clip did not remain engaged.Dhr investigation did not show issues related to complaint.It could not be conclusively determined what caused the clip to be misloaded into the applier for this procedure.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: HOL L 10MM ENDO APPLIER
• 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17714344
• Report Number: 3011137372-2023-00218
• Device Sequence Number: 2251058
• Product Code: GDO
• UDI-Device Identifier: 34026704623649
• UDI-Public: 34026704623649
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Followup,Followup
• Report Date (Section B): 08/26/2023

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: 544995
• Device Lot Number: 06A2244779
• 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: 08/26/2023
• Supplement Date Received by Manufacturer: 12/01/2023; 12/01/2023; 03/19/2024
• Initial Report FDA Received Date: 09/08/2023
• Supplement Report FDA Received Date: 12/04/2023; 12/12/2023; 03/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.; N/A.; N/A.
• Patient Sex: Unknown