MAUDE Adverse Event Report: KARL STORZ ENDOSCOPY; CYSTOSCOPE

Model Number 27005BIA

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Information (3190)

Event Date 11/13/2014

Event Type  malfunction  

Event Description

During blue light procedure, doctor noticed 30 and 70 degree scopes not working with poor visibility.Doctor was unable to proceed; no other scopes available.Unable to perform procedure as intended.Event has been identified as use error.
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manufacturer response for blue light cystoscope, (brand not provided) (per site reporter).
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both scope's have been removed from service.They have been arranged to be serviced on 11/14/2014, by or solutions.

• Type of Device: CYSTOSCOPE
• Manufacturer (Section D): KARL STORZ ENDOSCOPY; 2151 e. grand avenue; el segundo CA 90245 501
• MDR Report Key: 4264095
• MDR Text Key: 15115363
• Report Number: 4264095
• Device Sequence Number: 1
• Product Code: FBO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 11/18/2014
• 2 Devices were Involved in the Event: 1 2

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: 27005BIA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2014
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/18/2014
• Event Location: Hospital
• Date Report to Manufacturer: 11/20/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/18/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 76 YR