MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. URETERO-RENO FIBERSCOPE

Model Number URF-P6

Device Problems Break (1069); Fracture (1260); Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/09/2017

Event Type  malfunction  

Manufacturer Narrative

This device referenced in this report was returned to omsc for evaluation.The evaluation of the subject device by omsc confirmed following.- as reported from the user facility, a part of the adhesive of bending rubber of the subject device was peeled off.- the analysis gave that the black fragment which fall off was the adhesive of bending rubber.Omsc reviewed the manufacturing history of the subject device and confirmed no irregularity.It was surmised that the reported phenomenon might be caused due to interfering with other hard objects, however, the exact cause of the event could not be conclusively determined at this moment.If additional and significant information becomes available, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed that the doctor found a semicircular black fragment (size about 1 mm in length, 1.5 mm in width) into the patient's bladder during a transurethral urolithiasis surgery.The user facility retrieved the fragment and the intended procedure was completed with the subject device.After the user removed the subject device from the patient, it was confirmed that the adhesive of bending rubber of the subject device was peeled off.There was no patient injury in this event.

• Brand Name: URETERO-RENO FIBERSCOPE
• Type of Device: URETERO-RENO FIBERSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: katsuaki morita ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 7085889
• MDR Text Key: 95738288
• Report Number: 8010047-2017-01926
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK912120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/06/2017

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: Health Professional
• Device Model Number: URF-P6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2017
• Initial Date Manufacturer Received: 11/10/2017
• Initial Date FDA Received: 12/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/18/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1