MAUDE Adverse Event Report: GYRUS ACMI, INC ELITE 2 SYSTEM CF RESECTOSCOPE OUTER SHEATH, 27FR

Model Number	E2OS-CF27
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during preparation for use, the ceramic tip was found broken.There is no patient involvement associated on this reported event.No user injury reported.
Additional Manufacturer Narrative
The subject device was received and evaluated.Device evaluation and inspection found , the complaint was confirmed.The insulation tip was broken and damaged.No additional defects were noted.Device history records were reviewed and showed the product met all specifications upon release.The device ifu (rev 99-1078_bh) states: "study this manual and other labeling thoroughly for safe handling, storage and usage, including instructions for all generators and accessories.Failure to properly follow the instructions, warnings, and cautions may lead to serious surgical consequences or injury to the patient.Misuse of instruments can cause injury to the patient and could have an adverse effect on the procedure being performed.Do not drop instruments, or allow them to be struck by other objects;" and "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." (page 4).Investigation is ongoing.This report will be supplemented accordingly following investigation completion.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.H4 - device was manufactured in february 2017.Based on the results of the investigation, the cause of the damage likely occurred due to impact of dropping the device.The specific root cause could not be determined at this time.Olympus will continue to monitor field performance for this device.

• Brand Name: ELITE 2 SYSTEM CF RESECTOSCOPE OUTER SHEATH, 27FR
• Common Device Name: RESECTOSCOPE OUTER SHEATH
• 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: 13765081
• Report Number: 1519132-2022-00001
• Device Sequence Number: 12010255
• Product Code: FAS
• UDI-Device Identifier: 00821925003477
• UDI-Public: 00821925003477
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2022

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: E2OS-CF27
• Device Lot Number: CA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2022
• 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: 02/15/2022
• Supplement Date Received by Manufacturer: 03/16/2022
• Initial Report FDA Received Date: 03/15/2022
• Supplement Report FDA Received Date: 04/13/2022
• 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