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

Model Number	MH-946
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No device was returned to olympus for evaluation.However, as part of the investigation into this report, an olympus endoscopy support specialist (ess) has been dispatched on-site to assess the reprocessing practices at the user facility.
Event or Problem Description
Olympus was informed that during an onsite visit, the user facility staff was not reprocessing the injection tube after each use.No patient infections or injuries reported.
Event or Problem Description
The customer requested an olympus endoscopy support specialist conduct a reprocessing in-service.While onsite, it was discovered the customer was not reprocessing the auxiliary water tube, suction cleaning adapter, and injection tube after each use.There was no report of patient harm associated with this event.Related patient identifiers: (b)(6).
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Correction to b5 and h10 for information inadvertently left out of previous report.Three attempts were performed to obtain additional information, but no response was received from the customer.Olympus endoscopy support specialist while on-site reviewed reprocessing of a colonovideoscope, auxiliary water tube, suction cleaning adapter, and injection tube according to the reprocessing manual.It was recommended to reprocess the auxiliary water tube, suction cleaning adapter, and injection tube according to the manual.The options of soaking in high level disinfectant or steam sterilization after each use were discussed.The device history record was unable to be reviewed for this device since the lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, it is likely there was a difference in recognition on item handling or reprocessing steps between olympus recommendation and the user facility.Olympus expert staff has already conducted training on proper item handling for the user facility.Preventive measure is described in evis exera ii gif/cf/pcf type 180 series reprocessing manual chapter 5 reprocessing the endoscope (and related reprocessing accessories).Olympus will continue to monitor field performance for this device.

• Brand Name: INJECTION TUBE
• Common Device Name: INJECTION TUBE
• 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: 18146513
• Report Number: 9610595-2023-17409
• Device Sequence Number: 20711009
• Product Code: FET
• UDI-Device Identifier: 04953170286421
• UDI-Public: 04953170286421
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K954451
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2023

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
• Operator of Device: Health Professional
• Device Model Number: MH-946
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2023
• Supplement Date Received by Manufacturer: 12/04/2023
• Initial Report FDA Received Date: 11/16/2023
• Supplement Report FDA Received Date: 12/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown