MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. ENDOSCOPE

Model Number UNKNOWN

Device Problems Problem with Sterilization (1596); Device Contamination with Chemical or Other Material (2944)

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

Event Type  malfunction  

Event Description

Olympus received information from a news article titled "finding the 'flecks': ns health teams investigating endoscopy cleaning issue." the article reported that unexplained black flecks were turning up on endoscopy equipment after being sterilized, which impacted several machines of varying ages and locations.The problem resulted in hundreds of postponements and rescheduled procedures as the user facility paused procedures when the issue was flagged.The user facility was reportedly conducting a thorough and methodical investigation into the possible source of the black flecks including several comprehensive water tests and engaging an external consultant to evaluate the water.There was no further patient impact reported.An olympus representative noted that the user facility was a very old hospital, and the water quality was not the best.Due to the black fleck issue, 3 out 4 endo suites were shut down.The user facility was also very pro-olympus.The company representative confirmed that the user facility uses a third-party reprocessor.This event is captured under the related patient identifiers (b)(6) to cover the unspecified number of machines affected that resulted to postponements and rescheduled procedures.This medwatch is for patient identifier (b)(6).

Manufacturer Narrative

Since the article described endoscopy equipment, olympus selected fdt as a representative device product code for reporting purposes.The suspect device has not been returned to olympus.Additional information is being requested.The article is attached for additional information.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information is received.

Manufacturer Narrative

This report is being supplemented to provide additional information received from the customer as reflected on b5.

Event Description

Olympus further received information that the customer has confirmed that the incident occurred with a third-party reprocessor.They have no further details related to the incident.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the serial/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, the root cause of the reported event could not be identified.This supplemental report includes a correction to g2 to provide information that was inadvertently not included in the initial medwatch.Olympus will continue to monitor field performance for this device.

• Brand Name: ENDOSCOPE
• Type of Device: ENDOSCOPE
• 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: 17731068
• MDR Text Key: 323495573
• Report Number: 9610595-2023-13194
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/29/2023
• 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