MAUDE Adverse Event Report: KARL STORZ GMBH & CO. KG N.A.; URETHROSCOPE

Model Number 27023FM

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/13/2017

Event Type  malfunction  

Event Description

The end of the flexible grasping forceps broke off into the patient's bladder.We removed the long end and used another cystoscope and grasper to look for it.Doctor looked and looked for it, found it once but was unable to remove it.He said the patient should pass it on his own because it is smaller than the stones that were coming out.From op report: i used a small flexible grasper through the flexible scope but that grasper failed.The grasper broke and i was unable to retrieve it without removing the flexible scope.Therefore i removed the flexible scope and used a rigid scope and performed cystoscopy.I was able to grasp the stent easily with that and remove stent.I then inspected the flexible scope and i noted that a tiny piece of the flexible grasper was not present on the grasping device.I presumed that this small piece which was only 1 mm in length and less than a millimeter in width was still in the patient's bladder.I inspected the bladder and was able to find this missing piece which is very small.If it is in his bladder it should be small enough to pass as it is smaller than the fragments that we expected pass with the lithotripsy.

• Brand Name: N.A.
• Type of Device: URETHROSCOPE
• Manufacturer (Section D): KARL STORZ GMBH & CO. KG; 2151 e. grand avenue; el segundo CA 90245
• MDR Report Key: 6882164
• MDR Text Key: 86890308
• Report Number: 6882164
• Device Sequence Number: 1
• Product Code: FBO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/15/2017

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: Physician
• Device Model Number: 27023FM
• Device Lot Number: PT02
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/15/2017
• Event Location: Hospital
• Date Report to Manufacturer: 09/15/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NOT APPLICABLE.
• Patient Age: 64 YR
• Patient Weight: 131