MAUDE Adverse Event Report: HEMOLOK CLIP; HEMOCLIPS

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Stenosis (2263)

Event Date 01/01/2009

Event Type  malfunction  

Event Description

Alleged issue: (b)(6) and et al, dept of urology, (b)(6) wrote the following case article found in the internet journal of laparoendoscopic and advanced surgical techniques, 2009: a (b)(6) who had undergone a laparoscopic radical prostatectomy and returned 8 months later for follow-up investigations due to intractable urinary symptoms.A flexible cystoscopy revealed a tight bladder neck.A hem-o-lok was found in the bladder, having migrated form the urethrovesical anastomosis, and was successfully removed (see tc # (b)(4)).On repeat cystoscopy 3 months later, a further hem-o-lok device was found eroded through the vesicourethral anastomosis and was successfully removed with the aid of a holmium laser.

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: 3908399
• MDR Text Key: 4665975
• Report Number: 3003898360-2014-00360
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,User Facility
• Reporter Occupation: Not Applicable
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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