MAUDE Adverse Event Report: OLYMPUS CORPORATION OF THE AMERICAS; UTEROSCOPE

Model Number URF-V

Device Problems Break (1069); Leak/Splash (1354); Material Too Rigid or Stiff (1544)

Patient Problem No Information (3190)

Event Date 02/20/2014

Event Type  malfunction  

Event Description

The flexible olympus ureteroscope was requested and opened for the sterile field.The scrub tech examined the scope and it was determined the tip was not flexing properly.With further examination the scrub tech and surgeon discovered several spots along the length of the scope.When the surgeon wiped his finger along the spot, it came off.The scope was immediately passed off the field.Sterile processing ran a bioburden test which came back positive.The scope was found to have multiple leaks from various spots.
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manufacturer response for olympus scope, olympus (per site reporter)
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the scope has multiple leaks from various damaged spots.

• Type of Device: UTEROSCOPE
• Manufacturer (Section D): OLYMPUS CORPORATION OF THE AMERICAS; 3500 corporate pkwy; center valley PA 18034
• MDR Report Key: 4092162
• MDR Text Key: 4831666
• Report Number: 4092162
• Device Sequence Number: 1
• Product Code: FGB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/08/2014

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: Physician
• Device Model Number: URF-V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/08/2014
• Event Location: Hospital
• Date Report to Manufacturer: 09/16/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/08/2014
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 83