MAUDE Adverse Event Report: GYRUS ACMI, INC. M3-GOLD AUTOCLAVABLE FOROBLIQUE TELESCOPE 30 DEG; HYSTEROSCOPE (AND ACCESSORIES)

Model Number REXM3-30A

Device Problem Device Reprocessing Problem (1091)

Patient Problem Unspecified Infection (1930)

Event Date 12/15/2023

Event Type  Injury  

Manufacturer Narrative

The suspect device referenced in this report has not been returned to olympus.Additional information is being requested.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information is received.

Event Description

The customer reported to olympus that a patient with bladder cancer developed an unspecified infection after the m3-gold autoclavable foroblique telescope 30 deg was used.As such, the customer wanted to know the best high-level way to disinfect the scope.The customer was provided with the instructions for use (ifu) for the scope and was advised that steam was normally preferred.The customer stated that she read somewhere on the internet that steam cannot be used to sterilize the scopes.The customer was advised that the m3-30a can be sterilized in steam.The customer seemed to have been confused with some information found on the internet about the autoclavability of the scope.Additional information has been requested but no further information was provided at this time.

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.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, since the device was not returned to olympus for evaluation, the reported issue could not be confirmed.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿section 6.3 sterilization: m3-gold telescopes may be sterilized in a steam sterilizer controlled within the parameters.¿.This supplemental report includes a correction to the following fields: d4, d8, and g2.Also, information has been added to h4.Olympus will continue to monitor field performance for this device.

• Brand Name: M3-GOLD AUTOCLAVABLE FOROBLIQUE TELESCOPE 30 DEG
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): GYRUS ACMI, INC.; 800 west park drive; westborough MA 01581
• Manufacturer (Section G): GYRUS ACMI, INC.; 800 west park drive; westborough MA 01581
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18443840
• MDR Text Key: 331887684
• Report Number: 3003790304-2024-00004
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K890328
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/15/2024

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
• Device Operator: Health Professional
• Device Model Number: REXM3-30A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/15/2023
• Initial Date FDA Received: 01/04/2024
• Supplement Dates Manufacturer Received: 02/06/2024
• Supplement Dates FDA Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2013
• 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
• Patient Outcome(s): Other