MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. URETERO-RENO FIBERSCOPE

Model Number URF-P7

Device Problem Failure to Clean Adequately (4048)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/26/2024

Event Type  Injury  

Manufacturer Narrative

This report is related to the following linked patient identifier: (b)(6).The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported during a diagnostic renal pelvic and ureteral examination, when the forceps was inserted into the forceps channel of the uretero-reno fiberscope, there was some resistance to insertion and a black foreign object fell from the tip into the renal pelvis.The foreign object was recovered using forceps.The doctor then replaced the scope and completed the procedure.There was no prolongation of the procedure or additional anesthesia.Upon customer follow-up, it was reported that the rubber stopper of the forceps/irrigation plug used in the previous case was partially broken and went inside the scope channel.During reprocessing, the inside of the channel was not brushed completely and the broken forceps/irrigation plug pieces were not completely removed and subsequently fell into the patient in the next procedure.There was no reported patient impact.

Manufacturer Narrative

This report is being supplemented to provide additional information, based on the legal manufacturer's final investigation and device evaluation.Additionally, to provide a correction to the initial with information inadvertently left out (g2 and h10).To provide a correction to field (h4).And to provide an update to fields (h3).The device was evaluated by olympus.And an foreign object was confirmed, in the subject device.Additional information inadvertently left out: it was reported, that there was no delay in the start of precleaning.The user did not aspirate the water through the instrument/suction channel.No abnormalities in the accessories used for reprocessing.The user wiped/brushed the instrument channel outlet with clean lint-free cloths, brushes or sponge.A review of the device history record found no deviations, that could have caused or contributed to the reported issue.Based on the results of the investigation, olympus judged that the foreign material was a part of the biopsy valve of forceps tightening knob from the obtained information in the related complaint.Additionally, it is likely, the foreign material remained in the nozzle, since the reprocessing was deviated from the instruction manual.However, the specific root cause of the reported event could not be identified.The event can be detected/prevented, by following the instructions for use, which state: ¿chapter 3: preparation and inspection: section 3.3; inspection of the endoscope and section 3.8; inspection of the endoscopic system¿.Olympus will continue to monitor field performance for this device.

• Brand Name: URETERO-RENO FIBERSCOPE
• Type of Device: URETERO-RENO FIBERSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19071820
• MDR Text Key: 339722085
• Report Number: 9610595-2024-07400
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170435096
• UDI-Public: 04953170435096
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K181451
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/09/2024

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-P7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2024
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/26/2024
• Initial Date FDA Received: 04/09/2024
• Supplement Dates Manufacturer Received: 05/09/2024
• Supplement Dates FDA Received: 05/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2021
• 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
• Treatment: MAJ-891
• Patient Outcome(s): Required Intervention