MAUDE Adverse Event Report: GYRUS ACMI, INC NON-CF RESECTOSCOPE METAL BROWN BEAK SHEATH; HYSTEROSCOPE (AND ACCESSORIES)

Model Number	EMRS-26B
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
The device is returned and an evaluation completed for it.The user¿s complaint was confirmed.Upon inspection of the device, the white tip is found to be broken.The missing fragments are not returned.The break has likely happened due to impact such as dropping of the device.Evaluation is ongoing.Supplemental report(s) will be submitted when any relevant new information is available.
Event or Problem Description
The device was returned for evaluation and repair for the breaking of the white tip that occurred during installation.There is no patient involvement.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device met all specifications at the time of shipment.Based on the results of the investigation, it was confirmed the break likely occurred due to impact such as dropping of the device.The definitive root cause of the reported issue could not be determined.The following information is stated in the instructions for use: "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 field performance for this device.

• Brand Name: NON-CF RESECTOSCOPE METAL BROWN BEAK SHEATH
• Common Device Name: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• Manufacturer Contact: brian motter ; 93 north pleasant st.; norwalk, OH 44857 ; 4848965250
• MDR Report Key: 14277656
• Report Number: 1519132-2022-00006
• Device Sequence Number: 19986736
• Product Code: HIH
• UDI-Device Identifier: 00821925001992
• UDI-Public: 00821925001992
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2022

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: EMRS-26B
• Device Lot Number: MD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2022
• 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: 04/08/2022
• Supplement Date Received by Manufacturer: 05/10/2022
• Initial Report FDA Received Date: 05/04/2022
• Supplement Report FDA Received Date: 06/08/2022
• Date Device Manufactured: 12/19/2020
• 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