MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH INNER SHEATH, LONG, FOR WA22018A AND WA22019A; RESECTOSCOPE SHEATH

Model Number	WA22017A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer returned the inner (resectoscope) sheath to olympus for a reported ¿repair needed¿.There was no defect or malfunction specified.However, during the device evaluation, the following reportable malfunction was identified: the ceramic insulation at the distal tip of the sheath was missing.No death or injury and no impact to patient or other has been reported.
Additional Manufacturer Narrative
The referenced device was returned to olympus repair and the evaluation found : the ceramic insulation at the distal tip of the sheath was missing.The evaluation also noted the sealing set is worn out and the laser markings are worn/faded.The investigation is still in progress; however, should additional relevant information become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the approved final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the definitive root cause of the damaged ceramic tip could not be determined.It is possible that the tip was damaged due to user handling such as impact, drop, or a fall.The instruction manual identifies the following verbiage, which may have prevented the phenomenon: ¿warning infection control risk: properly reprocess the product before first and each subsequent use following the instructions in this manual and in the system guide endoscopy.Improper and/or incomplete reprocessing can cause infection of the patient and/or medical personnel.4.1 inspection and testing inspecting the product: visually inspect the product.Make sure that it has: -- no corrosion -- no dents -- no scratches ceramic insulation at distal end: visually inspect the ceramic insulation at the sheath¿s distal end before each use.Do not use the instrument in case of damage (e.G.Cracks, fractures).Warning risk of injury: impact, fall, shock, or similar stress can damage the ceramic insulation at the sheath¿s distal end.Damaged instruments can cause injuries to the patient and/or user.Do not use the instrument if damaged.Damaged product: if the product is damaged or does not function properly, contact an olympus representative or an authorized service center.¿ olympus will continue to monitor field performance for this device.

• Brand Name: INNER SHEATH, LONG, FOR WA22018A AND WA22019A
• Common Device Name: RESECTOSCOPE SHEATH
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, de 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17878273
• Report Number: 9610773-2023-02823
• Device Sequence Number: 7760307
• Product Code: HIH
• UDI-Device Identifier: 04042761051514
• UDI-Public: 04042761051514
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K931994
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2023

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: WA22017A
• Device Lot Number: 22502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2023
• Supplement Date Received by Manufacturer: 10/09/2023
• Initial Report FDA Received Date: 10/05/2023
• Supplement Report FDA Received Date: 10/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2022
• 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