MAUDE Adverse Event Report: GYRUS ACMI, INC URETEROSCOPE, 33CM; URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number	REXMR-6A
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Burn(s) (1757)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device referenced in this report has been returned to olympus , but not yet evaluated.The definitive cause of the user's experience cannot be determined at this time.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.
Event or Problem Description
The customer reports during an unspecified procedure using a semi rigid ureteroscope, the scope got hot when connected to the light cord and the patient experienced a burn on his penis.The severity of the burn is unknown.It is unknown if what/if the patient required any treatment or intervention for the burn.Additional details have been requested from the customer, at this time, no additional information has been provided.
Additional Manufacturer Narrative
This report is being updated to correct data reported in d4, model number and udi.
Additional Manufacturer Narrative
This report is being updated to provide investigation findings.The returned device was evaluated on 10jun2022 by olympus.The complaint was not confirmed.- the unit was connected to the clv-190 light source while powered on for about 2 hours.At random times during the burn-in tests, the distal end of the mr-6a was placed on the inspector¿s hand for several seconds, and no burning sensation occurred.-the burn test was also conducted by production team.The scope was connected to the sources for more than an hour, and unable to confirm the reported issue of scope heating up.In addition, the inspection found the light guide post was scratched and damaged, minor scratches and debris under eyepiece cover glass.The customer¿s light cord returned was also inspected.The contact surface of the cord connector was scratched and damaged.The model number of the cord was unknown, the number printed on the cord, 182133, was an invalid olympus¿ model number.A functional test on this unit could not be performed as the connector plug does not fit into any light sources available at olympus san jose facility.Dhrs (device history records) for this product has been reviewed.The device was an rex scope manufactured 10mar2021.All records showed the product met all specifications upon release.Based on the investigation, a probable root cause of the reported failure was not attributed to the mr endoscope.However, a definitive root cause of the reported complaint could not be determined at this time.As the overall incidence is remote (n=1) and a probable root cause of the reported failure was not attributed to the mr endoscope, no additional actions are required at this time.Olympus will continue to monitor the field performance of this device.The device instructions for use (ifu) states "when instruments from different manufacturers are used together, verify that any isolation or grounding is not violated; prior to use, examine each electrode and its insulation for damage; do not use if damaged." (warnings, page 4).

• Brand Name: URETEROSCOPE, 33CM
• Common Device Name: URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• Manufacturer Contact: brian motter ; 800 west park drive; westborough, MA 01581 ; 4848965250
• MDR Report Key: 14644865
• Report Number: 3003790304-2022-00097
• Device Sequence Number: 17521447
• Product Code: FGB
• UDI-Device Identifier: 00821925007826
• UDI-Public: 00821925007826
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K052044
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/02/2022

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: REXMR-6A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2022
• 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: 05/13/2022
• Supplement Date Received by Manufacturer: 07/01/2022; 07/29/2022
• Initial Report FDA Received Date: 06/09/2022
• Supplement Report FDA Received Date: 07/29/2022; 08/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/10/2021
• 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: UNSPECIFIED LIGHT CORD.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male