MAUDE Adverse Event Report: GYRUS ACMI L.P. CF RESECTOSCOPE INNER SHEATH, 25FR

Model Number	EIS-HCF25
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned and evaluated, and the customer¿s allegation was not confirmed.The beak of the sheath was cracked, and a portion was missing.The labels were also not properly affixed, and repair was recommended.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Event or Problem Description
The customer reported to olympus that there was a broken tip while using the cf resectoscope inner sheath, 25fr.The issue occurred during reprocessing, and there was no procedural impact or patient harm associated with the event.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Please see the updates in sections d4 (lot number), h4, h6, and h10.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 4 years since the subject device was manufactured.Based on the results of the investigation, it is likely the beak was cracked with missing fragments was due to due to user mishandling during device reprocessing.However, a definitive root cause could not be determined.The following information is stated in the instructions for use (ifu): ¿ifu (instructions for use, rev 99-1033_fk) "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." (warnings#1, page 4); " 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." (warnings#3, page 4).¿ olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
This supplemental report is being submitted to inform the updates/correction on h10 from initial report information.This complaint device inner sheath unit received for evaluation and was evaluated is a lot control device and therefore the serial number ac22179419 noted in h10 on the initial report is not a valid serial number on this complaint.This ac22179419 is a service order number by default when the device is received.The evaluation performed was under the lot number ib.The investigation is ongoing.This report will be supplemented accordingly following investigation.
Additional Manufacturer Narrative
See correction in h6 ¿ investigation findings.
Additional Manufacturer Narrative
This report is being submitted to correct the legal manufacturer¿s contact information and facility registration number.The facility registration number is (b)(4).

• Brand Name: CF RESECTOSCOPE INNER SHEATH, 25FR
• Common Device Name: RESECTOSCOPE
• Manufacturer (Section D): GYRUS ACMI L.P.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer (Section G): GYRUS ACMI L.P.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16146325
• Report Number: 3003790304-2023-00012
• Device Sequence Number: 17603884
• Product Code: FAS
• UDI-Device Identifier: 00821925001893
• UDI-Public: 00821925001893
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 06/19/2024

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: EIS-HCF25
• Device Lot Number: IB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2023
• Supplement Date Received by Manufacturer: 01/12/2023; 01/23/2023; 01/23/2023; 06/19/2024
• Initial Report FDA Received Date: 01/12/2023
• Supplement Report FDA Received Date: 01/12/2023; 02/09/2023; 02/09/2023; 06/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2018
• 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