MAUDE Adverse Event Report: TELEFLEX MEDICAL HEM-O-LOK XL ENDO 10, APPLIER; APPLIER, SURGICAL, CLIP

Model Number	IPN915193
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.
Event or Problem Description
When the user ligated a renal artery with a clip during a laparoscopic nephrectomy , the clip got stuck in the applier.The user touched the clip carefully with a forceps, then the clip left the applier.The clip did not involve other tissue at ligation.Additional information: the clip got stuck in the applier after ligation, therefore, when the clip left the applier , ligation succeeded.
Additional Manufacturer Narrative
(b)(4).Per customer provided information we are unable to perform a thorough dhr review for the alleged defective device since lot information has not been provided and this instrument has not been returned for review or evaluation.We are unable to determine what may have caused the alleged defect or validate the alleged complaint.All devices of this type are 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
When the user ligated a renal artery with a clip during a laparoscopic nephrectomy , the clip got stuck in the applier.The user touched the clip carefully with a forceps, then the clip left the applier.The clip did not involve other tissue at ligation.Additional information: the clip got stuck in the applier after ligation, therefore, when the clip left the applier , ligation succeeded.
Additional Manufacturer Narrative
(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 50-piece lot in january of 2019.Evaluation of the returned instrument shows that there is no visible damage to the jaws, and they are properly aligned in the open and closed position and the open and closed jaw gaps measure to print specifications of.526 +.010/-.020 at (.512) and.004/.012 at (.008).We are unable to find any non-conforming features on this device.Functional evaluation shows that this instrument is able to pick-up, retain, close and release multiple clips both with and without the use of silastic test tubing as it did at time of manufacture.We are unable to validate this complaint as we were unable to replicate the alleged issue at the end user's facility.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
When the user ligated a renal artery with a clip during a laparoscopic nephrectomy, the clip got stuck in the applier.The user touched the clip carefully with a forceps, then the clip left the applier.The clip did not involve other tissue at ligation.Additional information: the clip got stuck in the applier after ligation, therefore, when the clip left the applier, ligation succeeded.

• Brand Name: HEM-O-LOK XL ENDO 10, 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: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 13939087
• Report Number: 3011137372-2022-00056
• Device Sequence Number: 4309221
• Product Code: GDO
• UDI-Device Identifier: 24026704696820
• UDI-Public: 24026704696820
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 03/09/2022

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: IPN915193
• Device Catalogue Number: 544990
• Device Lot Number: UNKNOWN
• 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: 03/09/2022
• Supplement Date Received by Manufacturer: 05/09/2022; 05/23/2022
• Initial Report FDA Received Date: 03/29/2022
• Supplement Report FDA Received Date: 05/09/2022; 05/24/2022
• 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