MAUDE Adverse Event Report: GYRUS ACMI, INC 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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device was returned to olympus for evaluation, upon inspection they confirmed the nose/tip of the device is cracked.The instructions for use (ifu) does state the following: (rev 99-1033_fj) with warnings given: "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) ; and "always keep sheaths parallel to one another when assembling and disassembling.If the inner sheath is inserted or removed at an angle to the outer sheath, the lateral force applied to the inner sheath may crack, loosen, break, or otherwise damage the sheath¿s insulated distal tip.A broken tip, or fragments of a damaged tip, can potentially pass through the outer sheath and into the patient.If drag or resistance is encountered during assembly or disassembly, stop¿align working element and sheath parallel to one another before proceeding." (page 14) the dhr was unable to be reviewed for this device since the lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.The reported event is likely due to design however with the product identifiers were not provided and root cause is unable to be determined.If additional information becomes available, this report will be supplemented accordingly.
Event or Problem Description
The customer reported the inner sheath tip broke on their cf resectoscope inner sheath, 25fr.Attempts to retrieve additional information from the customer are in progress.There were no reports of death, harm or injuries related to this event.
Event or Problem Description
The issue was discovered during preparation for use and the procedure was completed with another device.No consequences on patient.
Additional Manufacturer Narrative
This report is being submitted for additional information obtained from the customer.

• Brand Name: CF RESECTOSCOPE INNER SHEATH, 25FR
• Common Device Name: RESECTOSCOPE
• 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: 13773090
• Report Number: 1519132-2022-00002
• Device Sequence Number: 19792560
• 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: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2022

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: EIS-HCF25
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2022
• 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: 01/12/2022
• Supplement Date Received by Manufacturer: 03/18/2022
• Initial Report FDA Received Date: 03/15/2022
• Supplement Report FDA Received Date: 04/15/2022
• 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