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

Model Number URF-P6

Device Problems Material Separation (1562); Material Perforation (2205); Torn Material (3024)

Patient Problem Injury (2348)

Event Date 02/10/2016

Event Type  Injury  

Manufacturer Narrative

This device referenced in this report was returned to olympus (b)(4) for evaluation.The bending rubber was torn and it was stretched and folded towards the distal side.The bending section of the subject device worked within the specifications.The surgeon thought that the fragments of the stone came to the proximal side of the bending section and when the scope was withdrawn, the scope became trapped on the undulations, and then the bending section of the scope was damaged.The subject device became trapped possibly by stones between the subject device and the ureter.The manufacturing record of the subject device was reviewed without irregularity.If additional information becomes available at a later time, this report will be supplemented.

Event Description

Olympus was informed that upon completion of a laser lithotripsy procedure, the surgeon was unable to withdraw the subject device as it was stuck.The surgeon had to perform open surgery to cut the ureter and remove the scope and then implant the ureter.

Manufacturer Narrative

The device referenced in this report was sent to (b)(4) olympus for evaluation.According to the evaluation, the bending rubber was folded on the distal side and there was a cutting found on the proximal side.In addition, it was confirmed that there was a sliding mark on the insertion tube, and a cutting, uncounted pinholes on the bending rubber between 90mm and 50mm from the distal end on the up side, and between 90mm and 30mm on the down side.Nothing abnormal was confirmed on the bending shape and the bending movement.Further, a stain was found on the imager guide.From the above analysis, as a cause of this event, it is considered that the bending rubber was folded on the distal side and the diameter became larger, causing the scope to be stuck in the ureter.Though it has not been informed whether the user facility used the access sheath or not, if the access sheath was used, there is a possibility the distal end of the bending rubber was folded because the surgeon forcefully tried to withdraw the scope that was stuck in the access sheath.For the cause of the stain on the imager guide, it is considered that moisture was flooded through the cuttings or pinholes of the bending rubber.

• Brand Name: URETERO-RENO FIBERSCOPE
• Type of Device: URETERO-RENO FIBERSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951; ishikawa-cho; hachioji-shi, tokyo 192-8 507; JA 192-8507
• Manufacturer Contact: susumu nishina ; 2951; ishikawa-cho; hachioji-shi, tokyo 192-8-507 ; JA 192-8507 ; 6425177
• MDR Report Key: 5491365
• MDR Text Key: 40024105
• Report Number: 8010047-2016-00316
• Device Sequence Number: 1
• Product Code: FBN
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K#: K912120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: URF-P6
• Device Catalogue Number: URF-P6
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2015
• 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
• Patient Outcome(s): Other