MAUDE Adverse Event Report: FORTEC FIBERS, INC. HOLMIUM FIBER; POWERED LASER SURGICAL INSTRUMENT

Catalog Number SU-200-RT

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/12/2019

Event Type  malfunction  

Event Description

A left retrograde pyelogram was performed.A 11/13 boston scientific ureteral access sheath was advanced over the working wire and into the ureter under fluoroscopic guidance.It passed easily to the level of the renal pelvis.The inner dilator and working wire were then removed.A flex-x flexible ureteroscope was passed into the access sheath for examination of the ureter, renal pelvis, and calyces.There were multiple stones within the left kidney that were fragmented and basketed.Large left ureteral stone was fragmented a 273 micron holmium laser fiber and removed.There were 2 stones within the left kidney which were large enough to require fragmentation with the laser.Both of these were lasered into small fragments and the fragments were removed.A 2mm portion of the distal end of the holmium laser fiber broke off during the ureteral stone lithotripsy.Physician tried to basket this fragment, however it slipped out of the basket and he was unable to see where it went.Physician spent a significant amount of time attempting to find the laser fiber fragment, however, he was never able to find it.The fragment was too small to be located with radiographic imaging.

• Brand Name: HOLMIUM FIBER
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): FORTEC FIBERS, INC.; 6245 hudson crossing parkway; hudson OH 44236
• MDR Report Key: 8935358
• MDR Text Key: 155668879
• Report Number: 8935358
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/17/2019

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
• Device Catalogue Number: SU-200-RT
• Device Lot Number: M15302
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/17/2019
• Event Location: Hospital
• Date Report to Manufacturer: 08/27/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 22995 DA
• Patient Weight: 48