MAUDE Adverse Event Report: TELEFLEX MEDICAL CLIPS

Catalog Number SURGICAL UNKNOWN

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Hemorrhage/Bleeding (1888); Renal Impairment (4499)

Event Date 03/01/2012

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device is reportedly unavailable for investigation.Teleflex will continue to monitor and trend related events.

Event Description

Per our discussion the patient had a robotic prostatectomy 10 years ago.This was for prostate cancer.Four clips replaced on the particles.Over the last year he had developed blood in his urine.When this occurred he underwent full examination including cystoscopy.This has shown the patient to have clip erosion into the bladder neck.In doing so for clips removed by transurethral resection over a period of a couple cases.In doing so i was able to identify with the patient that he had no further clip and bleeding has subsided.However, he is having severe bladder dysfunction which includes difficulty with urination, need for self-catheterization, some degree of incontinence.He is currently pending at full urodynamic panel to assist with determining why his bladder has become non-functional.He is very unhappy with his current status as you can imagine.He has metal arjona time looking up similar events on the internet.Response to question of current condition: he has continued retention and difficulty voiding.As noted before it is difficult to see if this obstruction or some degree of bladder dysfunction.He is performing self-catheterization 5x daily and urodynamics are pending.

Manufacturer Narrative

(b)(4).Dhr review could not be conducted since the lot number was not provided.P/n was not provided, however, a part number from the family was use for the "verification of failure mode reported in the current manufacturing process" and was conducted as follows: 20 samples were taken from the current production p/n 544250 hemolok xl clips 6/cart 84/box, lot# 73f2200808, samples were functionally inspected, and during the test issue reported "clip migrated" was not observed in the current manufacturing process.Revision of pfmea-08-025 rev 06 was performed and the failure mode is already including it, no update is required.Corrective actions cannot be established since it is necessary to receive the physical sample to perform a proper investigation and confirm the alleged defect.At this time due the sample is not available is not possible to determine the source of the defect reported.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.

Event Description

Per our discussion the patient had a robotic prostatectomy 10 years ago.This was for prostate cancer.Four clips replaced on the particles.Over the last year he had developed blood in his urine.When this occurred he underwent full examination including cystoscopy.This has shown the patient to have clip erosion into the bladder neck.In doing so for clips removed by transurethral resection over a period of a couple cases.In doing so i was able to identify with the patient that he had no further clip and bleeding has subsided.However, he is having severe bladder dysfunction which includes difficulty with urination, need for self-catheterization, some degree of incontinence.He is currently pending at full urodynamic panel to assist with determining why his bladder has become non-functional.He is very unhappy with his current status as you can imagine.He has metal arjona time looking up similar events on the internet.Response to question of current condition: he has continued retention and difficulty voiding.As noted before it is difficult to see if this obstruction or some degree of bladder dysfunction.He is performing self-catheterization 5x daily and urodynamics are pending.

• Brand Name: CLIPS
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 13839332
• MDR Text Key: 287575696
• Report Number: 3003898360-2022-00077
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/01/2022

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: SURGICAL UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/01/2022
• Initial Date FDA Received: 03/21/2022
• Supplement Dates Manufacturer Received: 07/06/2022
• Supplement Dates FDA Received: 07/08/2022
• 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: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization; Required Intervention
• Patient Sex: Male