MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. COLORED SHORT CLIP

Model Number	HX-610-090SC
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to olympus for evaluation.Due to the nature of the reportable event, follow up regarding the cleaning sterilization and disinfection (cds) processes performed at the user facility was requested.Customer provided the following information: it is unknown if the device was cleaned, sanitized, and disinfected prior to being sent to for repair.It is unknown if there was time lag between the end of clinical use and the start of pre-washing.Pre-cleaning: it is unknown if the facility flushed the air/water nozzle with water and air.If it unknown if the facility flushed the air/water nozzle with detergent solution.It is unknown if the facility presoaked the endoscope in the detergent solution.It is unknown if the facility brushed points for air/water channel performed with clean lint ¿free cloths, brushes, sponges.It is unknown if the facility noted any abnormalities on the accessories used for reprocessing.Facility did not note any comments or concerns regarding reprocessing.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Event or Problem Description
The customer reported to olympus that during surgery, a previously used olympus yellow clip (single use rotatable clip fixing device) came out from the colonovideoscope.The issue was found at an unspecified procedure.The clip was recovered, and the procedure was completed with the same set of equipment.There were no reports of patient or user harm.This report is related to the following linked patient identifier: (b)(6).
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record (dhr) was unable to be reviewed for this device 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 event was caused by the following: the clip was sucked in during the suction operation of the endoscope.The clip was released in the endoscope.The instruction manual contains the following information: "when aspirating body fluid via the endoscope, be careful not to aspirate a clip or clip connector that has been dropped inside the body cavity, as this could clog up the suction channel or cause the clip/clip connector to be stuck in the suction valve, and disable the endoscope¿s suction function.If a clip or clip connector is accidentally aspirated into the endoscope, follow the procedure given in ¿¦ removal of an aspirated clip or clip connector¿ on page 18.".Olympus will continue to monitor field performance for this device.

• Brand Name: COLORED SHORT CLIP
• Common Device Name: COLORED SHORT CLIP
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18355811
• Report Number: 9614641-2023-01951
• Device Sequence Number: 20526943
• Product Code: PKL
• UDI-Device Identifier: 04953170200397
• UDI-Public: 04953170200397
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K013066
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2024

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: HX-610-090SC
• Device Lot Number: UNKNOWN
• 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: 12/04/2023
• Supplement Date Received by Manufacturer: 01/18/2024
• Initial Report FDA Received Date: 12/19/2023
• Supplement Report FDA Received Date: 01/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: CF-Q260AI
• Patient Sex: Unknown