MAUDE Adverse Event Report: HEMOLOK CLIP; HEMOCLIPS

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Erosion (1750)

Event Date 01/01/2009

Event Type  malfunction  

Event Description

Alleged issue: pereira arias and et al printed an article in actas urol esp, 2010 describing one case out of 230 procedures that underwent robotic radical prostatectomy that resulted in one endoscopic extraction of hem-o-lok and vasculars clip following erosion-migration into the bladder.

Manufacturer Narrative

The device history record review (dhr) could not be conducted since the lot number was not provided.Complaint cannot be confirmed since the sample was not available for investigation.The manufacturer will continue to monitor and trend relating complaints.

• Brand Name: HEMOLOK CLIP
• Type of Device: HEMOCLIPS
• Manufacturer Contact: effie jefferson, rn ; po box 12600; durham, NC 27709 ; 9194332672
• MDR Report Key: 3908413
• MDR Text Key: 18733594
• Report Number: 3003898360-2014-00355
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Type of Report: Initial
• Report Date: 05/31/2014

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/01/2014
• Initial Date FDA Received: 06/02/2014
• 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