MAUDE Adverse Event Report: GYRUS ACMI INC. REPAIR-EXCHANGE, USA ELITE CFR INNER SHEATH, 27FR; HYSTEROSCOPE (AND ACCESSORIES)

Model Number	REXEIS-CFR-27
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is being submitted as part of a retrospective review and remediation effort based on enhancements made to the company¿s mdr and complaint handling processes.Capas have been opened to manage the actions that are being taken to remediate this issue and ensure any required mdr reporting is completed.The device was returned to olympus for evaluation where service confirmed the customer's complaint.During the evaluation, the insulating tip was found broken and damaged.In addition, the plastic release button on the locking ring was missing.Based on inspection findings and incident information, the reported failure was most likely caused by improper handling during reprocessing of the device.A review of the device history record could not be performed because the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.This information is addressed in the instructions for use (ifu): ¿study this manual and other labeling thoroughly for safe handling, storage and usage, including instructions for all generators and accessories.Do not drop instruments, or allow them to be struck by other objects;" " do not use an instrument that fails to meet the criteria stated in the labeling or that has been damaged.Damage may result in the loss of the entire ceramic tip or fragments of the ceramic tip.If there is evidence of charring, burn spots, chips or cracks in the ceramic tip or surrounding area, do not use.¿ olympus will continue to monitor the field performance of this device.
Event or Problem Description
A user facility reported that during reprocessing of the device, the ceramic tip at the end of the sheath was broken on a hysteroscope.There was no patient injury or adverse event reported to olympus.

• Brand Name: REPAIR-EXCHANGE, USA ELITE CFR INNER SHEATH, 27FR
• Common Device Name: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): GYRUS ACMI INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer (Section G): GYRUS ACMI INC; 800 west park drive; westborough MA 01581
• Manufacturer Contact: todd brill ; 9600 louisiana avenue north; brooklyn park, MN 55445 ; 5082077661
• MDR Report Key: 15129219
• Report Number: 3011050570-2022-00099
• Device Sequence Number: 12124230
• Product Code: HIH
• UDI-Device Identifier: 00821925008199
• UDI-Public: 00821925008199
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K890328
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/29/2022

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: REXEIS-CFR-27
• Device Lot Number: RXCW
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2021
• Initial Report FDA Received Date: 07/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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