MAUDE Adverse Event Report: TELEFLEX MEDICAL HEM-O-LOK CLIP; CLIP, IMPLANTABLE

Catalog Number SURGICAL UNKNOWN

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Hematuria (2558); Dysuria (2684)

Event Date 12/20/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).N/a.Other remarks: n/a.Corrected data: n/a.

Event Description

The reported complaint comes from a medical journal.The report states, "a seventy-three-year-old man was introduced with a high psa level, and was diagnosed with prostate cancer ct3an0m0.His ipsa was 6.53ng/ml, and gleason score 4+3.After administration of lh-rh agonist for half a year, robot-assisted radical prostatectomy was performed, and the histopathological diagnosis was pt2c, gleason score 5+4, and rm0.No treatment was followed after surgery.Twenty-eight months after the operation, psa elevated to 0.72ng/ml, and gross hematuria began to appear.A whole-body search showed no metastasis, so salvage radiation was performed on the prostate bed.At that time, ct showed a calcification at the site of vesico-urethral anastomosis, and cystoscopy revealed a bladder stone attached to the hem-o-lok clip, so transurethral lithotripsy was performed.There was no past history of intra-abdominal or pelvic surgery, so we thought that the hem-o-lok clip used at prostatectomy had entered the bladder".No further information is available.

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.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.

Event Description

The reported complaint comes from a medical journal.The report states, "a seventy-three-year-old man was introduced with a high psa level, and was diagnosed with prostate cancer (b)(6).His ipsa was 6.53ng/ml, and gleason score 4+3.After administration of lh-rh agonist for half a year, robot-assisted radical prostatectomy was performed, and the histopathological diagnosis was pt2c, gleason score 5+4, and rm0.No treatment was followed after surgery.Twenty-eight months after the operation, psa elevated to 0.72ng/ml, and gross hematuria began to appear.A whole-body search showed no metastasis, so salvage radiation was performed on the prostate bed.At that time, ct showed a calcification at the site of vesico-urethral anastomosis, and cystoscopy revealed a bladder stone attached to the hem-o-lok clip, so transurethral lithotripsy was performed.There was no past history of intra-abdominal or pelvic surgery, so we thought that the hem-o-lok clip used at prostatectomy had entered the bladder".No further information is available.

• Brand Name: HEM-O-LOK CLIP
• 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17997126
• MDR Text Key: 326411542
• Report Number: 3003898360-2023-01444
• 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: Foreign,Literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SURGICAL UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/08/2023
• 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