MAUDE Adverse Event Report: TELEFLEX MEDICAL HEMOLOK CLIPS; CLIP, IMPLANTABLE

Catalog Number SURGICAL UNKNOWN

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Abdominal Pain (1685); Unspecified Kidney or Urinary Problem (4503)

Event Date 01/01/2022

Event Type  Injury  

Event Description

The report states that a "67-year-old man underwent a right nerve-sparing robot-assisted radical prostatectomy.Thirty-three months after the operation, he complained of pain during urination or lower abdominal pain.From ct findings and flexible cystoscopy findings, it was diagnosed that the hem-o-lok clip used during robot-assisted radical prostatectomy had migrated in the bladder.The clip was encrusted with stones and attached to one end of the vesicourethral anastomosis.It was removed transurethrally with a holmium laser.First, the superficial calculus portion was removed with a holmium laser.Then, the adhering tissue was carefully excised and the clip was removed.No bladder perforation or postoperative recurrence was observed.Complaint was published in the japan medical abstract society (jamas), issued in 2022.Additional information is no longer available".

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Qn#(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review could not be performed as the lot number and product code were not identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

The report states that a "67-year-old man underwent a right nerve-sparing robot-assisted radical prostatectomy.Thirty-three months after the operation, he complained of pain during urination or lower abdominal pain.From ct findings and flexible cystoscopy findings, it was diagnosed that the hem-o-lok clip used during robot-assisted radical prostatectomy had migrated in the bladder.The clip was encrusted with stones and attached to one end of the vesicourethral anastomosis.It was removed transurethrally with a holmium laser.First, the superficial calculus portion was removed with a holmium laser.Then, the adhering tissue was carefully excised and the clip was removed.No bladder perforation or postoperative recurrence was observed.Complaint was published in the japan medical abstract society (jamas), issued in 2022.Additional information is no longer available".

• Brand Name: HEMOLOK CLIPS
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17052441
• MDR Text Key: 316430564
• Report Number: 3003898360-2023-00814
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SURGICAL UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Male