MAUDE Adverse Event Report: TELEFLEX HEMOLOK L CLIPS 6/CARTRIDGE 84/BOX; LIGATING CLIPS

Catalog Number 544240

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Code Available (3191)

Event Date 09/11/2013

Event Type  Injury  

Event Description

Complaint alleges from the patient: "one of these surgical clips made its way through the wall of my bladder near the anastomosis, it was finally detected when it was about 40% into the bladder, with 60% still firmly embedded in my bladder wall, and it is though there may be another clip on a similar mission at the rear of my bladder.A bulge in the bladder wall is clearly visible on photos although the suspected clip has not yet penetrated the mucosa." the first clip was removed on (b)(6) 2013.Unknown type of surgery.No further info regarding patient's current condition.

Manufacturer Narrative

No device sample is available for investigation.No lot# was provided.A visual or functional inspection of the product involved in the complaint could not be conducted since the product was not returned.Dhr review could not be conducted since the lot number was not provided.Complaint can not 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.We will continue to monitor trending relating complaints.

• Brand Name: HEMOLOK L CLIPS 6/CARTRIDGE 84/BOX
• 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: elaine burkle, rn ; po box 12600; rtp, NC 27709 ; 9194334957
• MDR Report Key: 3763297
• MDR Text Key: 4465111
• Report Number: 3003898360-2014-00237
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 03/12/2014

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: 544240
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/31/2014
• Initial Date FDA Received: 04/08/2014
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention