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

Model Number URF-P5

Device Problems Sticking (1597); Device Dislodged or Dislocated (2923)

Patient Problem Injury (2348)

Event Date 04/03/2018

Event Type  Injury  

Manufacturer Narrative

The subject device was returned to omsc and currently under evaluation.Omsc reviewed the manufacturing history of the device and confirmed no irregularity.The exact cause of the reported event could not be conclusively determined at this time.If additional information is received, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed that the subject device stuck within the ureter of the patient during withdrawing of the device with a ureteral access sheath at the end of the transurethral lithotripsy (tul).It was reported that the access sheath could be withdrawn but the device could not.The user facility tried to withdraw the device by twisting the device but the endoscopic image of the device disappeared.Then, the user facility withdrew the device under x-ray fluoroscopic image.However, a part of the ureter was retrieved and withdrawn with the subject device.The user facility immediately changed the procedure into a laparotomy surgery to repair the ureter and completed the procedure.The period of the patient's hospitalization was prolonged.

Manufacturer Narrative

This supplemental report is being submitted to provide the evaluation result for the subject device by olympus medical systems corp.(omsc).The evaluation confirmed that the bending section was damaged and the insertion tube was terribly twisted (twisted more than 10 turns) at proximal side from the bending section while the distal end side of the bending section did not have damage (irregularity).There was no missing part.The details of the bending section damage were as follows; the bending section rubber was turned up, and foreign matter adhered to the turn up point.(component of the foreign matter was protein and was not from the subject device.) the bending tubes were deformed and twisted, and a part of the bending tube was detached from another tube within the bending section rubber.A part (coil pipe) inside of the bending tube was twisted.Furthermore, as a result of observation for the fracture surface of the detached bending tube, no evidence of fatigue fracture was observed and it was confirmed that the bending tube broke highly likely at once by excessive force.During reproductive experiment using other urf-5, when the torsional force was applied to the insertion tube in a condition where the bending tube of the urf-5 was fixed, the same damage as the subject device was confirmed.Therefore, it was surmised that during the withdrawing of the device from the patient an excessive torsional stress was applied to the subject device in a state where the bending tube was fixed, and the device broken.Since no other abnormality was found in the device as a result of evaluation, the exact cause of the reason why the device could not withdraw from the ureter of the patient could not be conclusively determined.

• Brand Name: OES URETERO-RENO FIBERSCOPE
• Type of Device: URETERO-RENO FIBERSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• MDR Report Key: 7457357
• MDR Text Key: 106393341
• Report Number: 8010047-2018-00731
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• PMA/PMN Number: PK912120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 07/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: URF-P5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/05/2018
• Initial Date FDA Received: 04/25/2018
• Supplement Dates Manufacturer Received: 06/18/2018
• Supplement Dates FDA Received: 07/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other