MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. 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  

Manufacturer Narrative

Following the report of the incorrect reprocessing, olympus dispatched a representative to correctly instruction 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 the attendance sheet.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.

Event Description

The customer reported that when reprocessing her olympus uretero-reno fiberscope, the staff was not taking apart the maj-891 cable that is attached to the scope to clean it separately.There was no patient involvement during this event.

Manufacturer Narrative

This supplemental report is being submitted to correct the manufacturer name and address.In addition, this report is to correct the mfr report number of the initial and supplemental, which were submitted under the mfr.Report 8010047-2022-09548 to the correct mfr reporting registration number to (b)(4).The manufacturer investigation results confirmed the reported issue of incorrect reprocessing as the user did not take apart the forceps/irrigation plug maj-891.A device history record review indicated the device was shipped in accordance with specifications.The repair history show the subject device has been repaired once in the last year.A complaint review was performed with no further escalation required.The instructions for use (ifu) indicate "disassembling the forceps/ irrigation plug - be sure to disassemble the forceps/ irrigation plug before it is cleaned, disinfected or sterilized.Otherwise, the forceps/ irrigation plug may not be properly cleaned/ disinfected / sterilized." the presumable cause is the user did not understand the reprocessing method described in the ifu and did not conduct reprocessing in accordance with the ifu.During the in-service it was recommended/ demonstrated to the customer to take apart the maj-891 for reprocessing per ifu.Additionally the customer was provided a picture on how to take it apart.

• 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 965-8 520; JA 965-8520
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14620308
• MDR Text Key: 301161311
• Report Number: 8010047-2022-09548
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2022
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2021
• 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 FORCEPS/ IRRIGATION PLUG