MAUDE Adverse Event Report: TELEFLEX MEDICAL HEM-O-LOK; CLIP APPLIER

Model Number 544965

Device Problems Break (1069); Migration or Expulsion of Device (1395)

Patient Problem No Code Available (3191)

Event Date 09/13/2019

Event Type  malfunction  

Event Description

Broken instrumentation parts got stuck within each other.The short semi-rigid ureteroscope broke while inside the patient.The 22-french rigid cystoscope and 30-degree lens was introduced per urethra, and the left ureteral stent was identified.It was grasped with the stent graspers and pulled to the urethral meatus.A guide wire was placed within the stent and advanced up to the level of the left kidney, followed by removal of the left ureteral stent in its entirety.The flexible ureteroscope was then advanced alongside the wire and inspection of the ureter revealed no abnormalities until the proximal ureter was encountered.However, there was a stone and it appeared to be extremely clean cut with a symmetrical shape that looked like a ring on its side.Using the 200 micron laser fiber at settings of 0.2 j and 45 hz, the stone material/encrustations immediately gave way and revealed that this was a migrated hem-o-lok clip.Given the patient's surgery for removal of a left renal mass, it seems likely that this clip migrated into her collecting system and eventually became stuck in her left ureter.The ends of the clip were situated proximally with the bend of the clip more distally.Trying to laser this clip proved to be extremely ineffective.Even increasing the settings to more powerful fragmenting (2.0 j and 20 hz) and dusting (1.0 j and 50 hz) settings were not successful.The clip was extremely resistant to the laser, even at these higher settings.Trying to grasp this clip with a flexible ureteroscope and a 2.4-french tipless basket was not productive in that the orientation of the clip was such that the clip ends were more proximal.These instruments were not effective in holding on to the hem-o-lok with much purchase.Eventually, the decision was made to reposition the clip up the left ureter and into the collecting system.This worked in the sense that the orientation of the clip flipped.Therefore, the clip ends were more distal and the turn of the clip was more proximal.The 2.4-french basket was able to continue to hold on to this clip and it was eventually fully extracted.Given the manipulation of trying to laser/break up the clip, the ureter was slightly edematous and the decision was made to replace the left ureteral stent.

• Brand Name: HEM-O-LOK
• Type of Device: CLIP APPLIER
• Manufacturer (Section D): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• MDR Report Key: 9289925
• MDR Text Key: 165462705
• Report Number: 9289925
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 544965
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2019
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/30/2019
• Event Location: Hospital
• Date Report to Manufacturer: 11/07/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 21900 DA
• Patient Weight: 76