MAUDE Adverse Event Report: TELEFLEX MEDICAL HEMOLOK XL CLIPS 6/CART 84/BOX; CLIP, IMPLANTABLE

Catalog Number	544250
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
Reported in a medical journal, the report states, "a 54-year-old man underwent a robot-assisted radical prostatectomy for prostate cancer on june 2014.He had been fine after the operation, but urinary frequency and hematuria occurred after 3 months.A 7 mm stone shadow was found in the bladder by ultrasound and ct scan, and a non-mobile stone was found at the 9 o'clock position at the vesicourethral anastomosis by cystoscopy.The patient was diagnosed as a bladder stone and transurethral bladder lithotripsy was performed.When the surface of the stone was crushed, the clip that had been used during the radical prostatectomy appeared from inside.The clip was removed with forceps, all stones were crushed and removed, and the surgery was completed.The patient has been fine after the surgery and no migration of the clip has been observed after that".No patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).N/a.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
Reported in a medical journal, the report states, "a 54-year-old man underwent a robot-assisted radical prostatectomy for prostate cancer on june 2014.He had been fine after the operation, but urinary frequency and hematuria occurred after 3 months.A 7 mm stone shadow was found in the bladder by ultrasound and ct scan, and a non-mobile stone was found at the 9 o'clock position at the vesicourethral anastomosis by cystoscopy.The patient was diagnosed as a bladder stone and transurethral bladder lithotripsy was performed.When the surface of the stone was crushed, the clip that had been used during the radical prostatectomy appeared from inside.The clip was removed with forceps, all stones were crushed and removed, and the surgery was completed.The patient has been fine after the surgery and no migration of the clip has been observed after that".No patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).Customer complaint cannot be confirmed due the product sample is not available to perform a proper investigation and determinate the root cause.Dhr review could not be conducted since the lot number was not provided.If the alleged defect samples become available at a later date, this complaint will be updated accordingly.Other remarks: n/a.Corrected data: n/a.

• Brand Name: HEMOLOK XL CLIPS 6/CART 84/BOX
• Common Device Name: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17998020
• Report Number: 3003898360-2023-01434
• Device Sequence Number: 6680618
• Product Code: FZP
• UDI-Device Identifier: 34026704625216
• UDI-Public: 34026704625216
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133202
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2023

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 Catalogue Number: 544250
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2023
• Supplement Date Received by Manufacturer: 11/07/2023
• Initial Report FDA Received Date: 10/24/2023
• Supplement Report FDA Received Date: 11/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 54 YR
• Patient Sex: Male