MAUDE Adverse Event Report: STORZ CYSTOSCOPE; PEDIATRIC CYSTOSCOPE

Model Number 9.5 CYSTOSCOPE

Device Problems Material Fragmentation (1261); Physical Resistance (2578); Device Damaged by Another Device (2915); Difficult to Advance (2920)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/23/2014

Event Type  malfunction  

Event Description

Md was doing a cystoscopy procedure using a 9.5 french pediatric cystoscope.He placed a 0.035 inch wire up the ureter without difficulty under fluoroscopy.He then tried to pass a 5-french catheter over the wire but it would not easily go through the scope.He then passed a 4-french catheter over the wire but it met resistance and it actually shaved a piece of plastic or silicone off the outside part of the catheter.Apparently, there was a sharp edge on the inside of the scope that shaved the catheter.The md removed the scope and got a new scope and passed a 0.025 inch wire along the other wire up the ureter without difficulty and removed the larger wire.The md concluded his intended procedure.He tried to remove the shaved piece of silicone that was in the bladder with the grasping forceps but could not get it out because it was floating at the very top of the bladder and it appeared to be quite small and the md was certain that the pt would void this out once the foley was removed.

• Brand Name: CYSTOSCOPE
• Type of Device: PEDIATRIC CYSTOSCOPE
• Manufacturer (Section D): STORZ; el segundo 9024 5
• MDR Report Key: 3906270
• MDR Text Key: 20653841
• Report Number: MW5036932
• Device Sequence Number: 1
• Product Code: FBO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/25/2014

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
• Device Model Number: 9.5 CYSTOSCOPE
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/26/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 5 YR