MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH INNER SHEATH, FOR 26 FR. OUTER SHEATH, WITH A22085A; RESECTOSCOPE SHEATH

Model Number	A22040T
Medical Device Problem Code	Unintended Ejection (1234)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the customer disposed of the device and is not available for inspection.The device will not be returned to olympus for evaluation.We are unable to determine a root cause for the reported event.If additional information becomes available or the device is returned for evaluation, a supplemental report will be filed.
Event or Problem Description
An olympus representative reported that a user facility was using an inner sheath during a procedure when the beak became dislodged.The ceramic tip broke off into the patient during a resection procedure.The tip was retrieved using grasping forceps.The procedure was completed using another resection sheath.No death, injury, or infection occurred as a result.No additional information has been obtained.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the manufacturer's investigation.As part of the investigation, and review of production records from the last two years and a review of the device instructions for use (ifu) were conducted.The lot number is not available.However, the manufacturing and quality control review was performed for the last 24 months of production and there are no non-conformities or deviations regarding the described issue.The root cause was unable to be determined.Based on the described damage pattern, it is assumed the insulation tip damage was caused by mechanical thermal influence.Thermal mechanical overload, improper handling, and mechanical impact like fall, shock, or other stress could damage the insulation material of the sheath.The ifu warns that the ceramic tip can break due to mechanically loading or thermally induced straining.It is the responsibility of the user to inspect the instrument prior to ever procedure.The risk due to this event has been reviewed and no further actions are required.Olympus will continue to monitor for similar events.

• Brand Name: INNER SHEATH, FOR 26 FR. OUTER SHEATH, WITH A22085A
• Common Device Name: RESECTOSCOPE SHEATH
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 11189386
• Report Number: 9610773-2021-00049
• Device Sequence Number: 19561920
• Product Code: HIH
• UDI-Device Identifier: 04042761029360
• UDI-Public: 04042761029360
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K931994
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2021

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: A22040T
• Device Catalogue Number: A22040T
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/22/2020
• Supplement Date Received by Manufacturer: 03/23/2021
• Initial Report FDA Received Date: 01/18/2021
• Supplement Report FDA Received Date: 03/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1