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

Model Number URF-V2

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Insufficient Information (4580)

Event Date 05/22/2021

Event Type  Injury  

Manufacturer Narrative

The subject device was not returned to omsc for evaluation but was returned to olympus (b)(4) olympus (b)(4) confirmed that the subject device was cut at the insertion section and the bending section was in bending state.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed from the user that during the ureteroscopic lithotomy with the subject device, subject device could not be withdraw and the up/down angulation control lever was stuck.The user performed x-ray inspection and found that the distal end and the bending section of the subject device were in bending state.The sheath of the flexible ureteroscope can withdraw normally when it is tilted, but it cannot withdraw when it is stuck.The user still could not withdraw the subject after the user cut the insertion section of the subject device.The user withdrew the subject device by the laparotomy.The user facility did not provide other detailed information.

Manufacturer Narrative

The subject device was returned to omsc for evaluation.Omsc found the following with the returned device: appearance check: - the user cut the subject device at the base of insertion section.Ns unit was separated from the device.- bending section slightly curved.Omsc applied external stress there by finger, which made the bending section straighten easily.- a-rubber was leaking at 2 points.Omsc identified a liner scratch such as connecting two leaking points on the up side, which is sign of contact with hard material such as calculus.Result of ct scan: - cable support was broken and fell into the bending tube where the bending section is slightly curved.- no other breakage was found at the bending tube.Inspection result of bending function: - to angulate the subject device, it is important that the a-wire smoothly moves in coil pipe and the bending tube moves smoothly.- omsc inspected the device, ns unit side and control section unit side separately, because the device was cut.- omsc confirmed that the bending section smoothly moved, pulling the exposed a-wire from breaking point of ns unit - omsc confirmed the a-wire smoothly moved in coil pipe, moving coil pipe covering a-wire in control body.Disassembly inspection: - cable support of bending tube was broken and fell into the bending tube as identified by ct.Other breakage was not found at the bending tube.Reproduction by test device: - omsc replicated the state of cable support fallen into the bending tube with test device and conducted reproduction test.The bending tube did not get stuck by operating the angulation control lever under this condition.Bending tube stuck was not reproduced even under the identified nonconformity (breakage of cable support) occurring condition.Omsc confirmed the following, asking the user via olympus china: - before not being able to withdraw the device, the user performed lithotomy.- it is in inferior calix where the distal end was caught.- bending tube was angulated toward down 180 degree.- the user cut ns-unit, but the angulated range was not changed.- after laparotomy, the user withdrew the device by straightening the distal end with tweezers.- the user confirmed that there was no calculus between the device and the inferior calix during laparotomy.However, omsc presumes that the distal end was actually touched by hard material in inferior calix because scratches were found at a-rubber of the subject device.Omsc reviewed the manufacture history (dhr) of the subject device and confirmed no irregularity.The exact cause of the reported phenomenon could not be conclusively determined.However, based upon the information from olympus china and investigation result of the omsc, omsc surmised that the reported phenomenon was attributed to the distal end being contacted with hard material such as calculus in inferior calix.

• Brand Name: URETERO-RENO VIDEOSCOPE
• Type of Device: URETERO-RENO VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 12006651
• MDR Text Key: 256468119
• Report Number: 8010047-2021-07588
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• PMA/PMN Number: K172246
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 10/10/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: URF-V2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/22/2021
• Initial Date FDA Received: 06/16/2021
• Supplement Dates Manufacturer Received: 09/15/2021
• Supplement Dates FDA Received: 10/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other