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

Model Number	MAJ-855
Medical Device Problem Codes	Device Reprocessing Problem (1091); Problem with Removal of Enzymatic Cleaner (1213); Failure to Clean Adequately (4048)
Health Effect - Clinical Codes	Chemical Exposure (2570); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported to olympus, the auxiliary water tube was mistakenly used in combination with a flushing pump in an undisinfected and unsterilized state at the facility in an endoscopy case.It was reported that the facility had two water tubes, one was used for inspection and the other was used for reprocessing.The facility mistakenly used the water tube for reprocessing during a case and as a result, the patient may have ingested endofresh which remained in the water tube pipeline.There were no reports of patient harm.
Additional Manufacturer Narrative
The device was not returned to olympus for evaluation.A clinical assessment was conducted on this case and it was found that this event did not meet the requirements of a serious injury (si) due to no health hazards being reported and no additional procedures/intervention being planned or needed.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide corrected and additional information based on further review.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and to provide additional information obtained through follow-up (b)(4).The device history record was unable to be reviewed for this device since the serial 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 that the suggested event occurred since the user mistakenly was aware of the maj-855 for reprocessing as the maj-855 for a procedure.However, the root cause of the suggested event could not be specified.The event can be prevented by following the instructions for use which state: ¿chapter 9 reprocessing¿ describes the following warning."failure to properly clean and high-level disinfect or sterilize endoscopic equipment after each examination can compromise patient safety.To minimize the risk of transmitting diseases from one patient to another, after each examination this instrument must undergo thorough manual cleaning followed by high-level disinfection or sterilization." olympus will continue to monitor field performance for this device.
Event or Problem Description
The customer confirmed the procedure was a diagnostic upper gastrointestinal routine examination.No delay in the procedure in which the subject device was used and the intended procedure was completed.It was realized at the end of the procedure that a non-sterile/disinfected pipeline was used.The patient has no past medical history.The device was inspected prior to use.No hospitalization due to outpatient.No hospitalizations due to events.The patient's current condition is no problem and no problem with exposure of the detergent.No medical intervention (i.E.Treatment outside the scope of the procedure) required as a result of the exposure to the detergent.The patient cannot confirm the material and the customer has the safety data sheet.

• Brand Name: AUXILIARY WATER TUBE
• Common Device Name: AUXILIARY WATER 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: 17733319
• Report Number: 9610595-2023-13227
• Device Sequence Number: 18080192
• Product Code: FDS
• UDI-Device Identifier: 04953170071508
• UDI-Public: 04953170071508
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MAJ-855
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/14/2023; 09/25/2023
• Initial Report FDA Received Date: 09/12/2023
• Supplement Report FDA Received Date: 09/18/2023; 10/04/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GIF-H290Z (B)(6).; OFP-2.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 62 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian