MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. FORCEPS/IRRIGATION PLUG (ISOLATED TYPE); FORCEPS/ IRRIGATION PLUG

Model Number MAJ-891

Device Problem Device Reprocessing Problem (1091)

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

Event Date 09/24/2021

Event Type  malfunction  

Manufacturer Narrative

In speaking with olympus technical support via the phone, the customer stated the facility received the notice on reprocessing recommendations for forceps/irrigation plug maj-891.The customer wanted to confirm that the item had to be disassembled prior to sterilization.The customer was advised, per the document, the item had to be disassembled prior to cleaning, disinfecting and sterilization.The customer explained there was uncertainty if the staff was disassembling prior to cleaning, disinfecting and sterilization.The customer acknowledged now that the facility had been notified, the maj-891 would be disassembled prior to cleaning and sterilization.An olympus endoscopy support specialist (ess) has been dispatched to observe the user facility¿s reprocessing practices from start to finish and provide a reprocessing in-service training, if necessary, to correct and address any reprocessing deviations.Additional information was requested from the reporter.A supplemental report will be submitted should additional information be made available.The subject device referenced in this report was not returned for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The customer reported an incorrect reprocessing technique.The facility inquired if the forceps/irrigation plug (isolated type) needed to be disassembled prior to sterilization.No patient involvement was reported.

Manufacturer Narrative

D4: ¿6878730¿ was written as lot number however, per the legal manufacture the number is an item code of the accessory.Therefore, they judged that the number was not appropriate one as lot number.E2/e3: multiple attempts were performed to obtain additional information, but no response was received from the customer.If additional information is obtained at a later date, a supplemental report will be submitted.This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Based on the results of the investigation, the cause of the event was insufficient training.The following guidance from the device instruction manual may have prevented the event."chapter 7 cleaning, disinfection and sterilization procedures: 7.3 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." an olympus endoscopy support specialist (ess) was dispatched to observe the user facility¿s reprocessing practices from start to finish and provide a reprocessing in-service training, if necessary, to correct and address any reprocessing deviations.Ess attempted to schedule an time to observe and if necessary train but the customer refused.The customer stated that olympus technical support (tac) answered their questions over the phone and that they do not need an in-service or an observation at this time.Olympus will continue to monitor.

• Brand Name: FORCEPS/IRRIGATION PLUG (ISOLATED TYPE)
• Type of Device: FORCEPS/ IRRIGATION PLUG
• 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: 12631707
• MDR Text Key: 276385881
• Report Number: 8010047-2021-13131
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170063114
• UDI-Public: 04953170063114
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K912120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2021
• 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: 6878730
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/02/2021
• 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