MAUDE Adverse Event Report: TELEFLEX HEMOLOK CLIPS SIZE UNKNOWN; LIGATING CLIPS

Catalog Number UNKNOWN

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2009

Event Type  Injury  

Event Description

Complaint alleges: it was reported that the pt underwent a robotic-assisted laparoscopic radical prostatectomy (ralp) in (b)(6) 2009 at the hospital.After undergoing the ralp, the pt subsequently received follow-up care for approximately 60-90 days during which time it was observed that his psa levels had not dropped to zero, as expected.The pt began prophylactic radiation for 5 to 6 weeks in early (b)(6) 2010.During his radiation treatment he reported pain and incontinence and was informed that was a side effect of radiation.These symptoms remained post-radiation and on or about (b)(6) 2013.The pt passed a hem-o-lok clip through his urinary system while micturating.It is reported that this clip migrated through the pt's bladder." no pt injury reported.

Manufacturer Narrative

No device sample is available for investigation.Device history record (dhr) review could not be conducted since the lot number was not provided.Complaint cannot be confirmed since the sample was not available for investigation, therefore, it is not possible to determine the root cause for the defect reported and a corrective action for it.However, the manufacturer will continue to monitor and trend relating complaints.

• Brand Name: HEMOLOK CLIPS SIZE UNKNOWN
• Type of Device: LIGATING CLIPS
• Manufacturer (Section D): TELEFLEX; tecate ; MX
• Manufacturer (Section G): TELEFLEX; prolongacion mision eusebio; kino # 1316, rancho el descanso; tecate, b.c. ; MX
• Manufacturer Contact: jasmine brown ; po box 12600; rtp, NC 27709 ; 9193614124
• MDR Report Key: 3839219
• MDR Text Key: 4411904
• Report Number: 3003898360-2014-00312
• 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,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/01/2014

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/01/2014
• Initial Date FDA Received: 05/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1