MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. FORCEPS/IRRIGATION PLUG (ISOLATED TYPE); FORCEPS/ IRRIGATION PLUG

Model Number MAJ-891

Device Problem Degraded (1153)

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

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to olympus for evaluation.It was explained to the customer the forceps/irrigation plug (isolated type) is not originally used for visera hysterovideoscope.In addition, the forceps/irrigation plug (isolated type) may cause infection if used without being decomposed.The dealer will explain to the facility how to thoroughly use the correct combination, how to disassemble, and cleaning, disinfection and sterilization (cds) of the devices involved.The investigation is ongoing.If additional information becomes available, this report will be supplemented accordingly.The following medwatch reports are related: patient identifiers (b)(6) (hyf-v) and (b)(6) (maj-891, this complaint).

Event Description

An olympus representative reported to olympus, on behalf of the customer, there was an inquiry regarding the cleaning method of the forceps/irrigation plug (isolated type) while connected to visera hysterovideoscope.The forceps/irrigation plug (isolated type) had been subjected to cleaning, disinfection and sterilization (cds) without being disassembled, therefore was rusty inside.There were no reports of patient harm associated with this event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the approved final investigation.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, and since the device was not returned for evaluation, the definitive root cause of the rusty forceps could not be determined.It is likely that reprocessing according to instruction manual ¿chapter 7 cleaning, disinfection and sterilization procedures¿ can prevent the rust.Olympus will continue to monitor field performance for this device.

• Brand Name: FORCEPS/IRRIGATION PLUG (ISOLATED TYPE)
• Type of Device: FORCEPS/ IRRIGATION PLUG
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer Contact: masaharu hirose ; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8-520 ; JA 965-8520 ; 426422891
• MDR Report Key: 15337704
• MDR Text Key: 305591836
• Report Number: 9610595-2022-01517
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170063114
• UDI-Public: 04953170063114
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K912120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/03/2022

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: MAJ-891
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/04/2022
• Initial Date FDA Received: 09/01/2022
• Supplement Dates Manufacturer Received: 10/06/2022
• Supplement Dates FDA Received: 11/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: HYF-V, SN (B)(6)