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

Model Number URF-P7

Device Problem Device Reprocessing Problem (1091)

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

Event Type  malfunction  

Event Description

The user facility requested a reprocessing in-service for uretero-reno fiberscope.An olympus endoscopy support specialist (ess) visited the customer and noted during the in-service, incorrect reprocessing was observed.There were no reports of patient harm associated with this event.This report is related to a previously reported event.Patient identifier : (b)(6) (maj-891).

Manufacturer Narrative

The olympus endoscopy support specialist (ess) observed the customer was not using the bw-411b brush during reprocessing.This step has been skipped during the reprocessing following the bw-400b brush.It was also observed, during reprocessing, the customer stated they do not take apart the maj-891 that is attached to the scope to clean it.Following the report of the incorrect reprocessing, olympus dispatched a representative to correctly instruct the hospital staff on the proper reprocessing techniques per the instructions for use (ifu).The in-service was complete on the subject device and all attendees reviewed and signed an attendance sheet.It was recommended customer brush the channels with the bw-411b brush following the bw-400b brush and to take part the maj-891 to reprocess in 4 sections.The device has not been returned for evaluation.If additional information becomes available prior to the conclusion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The investigation confirmed the reported event.A review of the device history record found no deviations that could have caused or contributed to the reported device problem.The cause was traced to the user facility reprocessing method differing from that of the device instructions for use (ifu).The occurrence of the reported incident can be prevented by adhering to the instructions for use (ifu), which state the following: ¿1.4 precautions: an insufficiently cleaned, disinfected or sterilized endoscope and/or accessories may pose an infection control risk to the patients and/or operators who contact them.5.5 manually cleaning the endoscope: equipment needed - prepare the following equipment.Bw-411b.¿ olympus will continue to monitor field performance for this device.

• 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: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14691337
• MDR Text Key: 301369262
• Report Number: 8010047-2022-10041
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170403811
• UDI-Public: 04953170403811
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181451
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/22/2022

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-P7
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/16/2022
• Initial Date FDA Received: 06/14/2022
• Supplement Dates Manufacturer Received: 06/24/2022
• Supplement Dates FDA Received: 07/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2021
• 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: BW-411B, NO SERIAL NUMBER PROVIDED; MAJ-891, NO SERIAL NUMBER PROVIDED