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

Model Number	E2OS-CF27
Medical Device Problem Codes	Break (1069); Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was received and evaluated.Device evaluation has confirmed the customer reported issue of "tip chipped".Device evaluation , service repair noted the device beyond economic repair due to pin holes found on sheath.Cracks found on beak.Corrosion/rust/stain observed on the device.Investigation is ongoing.This report will be supplemented accordingly following investigation.
Event or Problem Description
Customer reported with an issue of "tip chipped", device was sent for repair.The issue found during device reprocessing.No patient or other person was affected or involved in the event.No harm was reported.No patient harm, no user injury reported.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.H4: based on the lot number provided, the manufacturing date of the device was in the month of december 2014 but a specific date could not be identified.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 8 years since the subject device was manufactured.Based on the results of the investigation, the reported failure was most likely due to user mishandling, such as impact dropped.The final root cause was unable to be identified.The following is included in the instructions for use: "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." olympus will continue to monitor field performance for this device.

• Brand Name: ELITE 2 SYSTEM CF RESECTOSCOPE OUTER SHEATH, 27FR
• Common Device Name: RESECTOSCOPE
• Manufacturer (Section D): GYRUS ACMI, INC.; 93 north pleasant st.; norwalk OH 44857
• Manufacturer (Section G): GYRUS ACMI, INC.; 93 north pleasant st.; norwalk OH 44857
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16274322
• Report Number: 1519132-2023-00006
• Device Sequence Number: 17650554
• 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,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2023

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: KT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2023
• Supplement Date Received by Manufacturer: 02/03/2023
• Initial Report FDA Received Date: 01/31/2023
• Supplement Report FDA Received Date: 02/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2014
• 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