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

Model Number	A22040T
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported during an unspecified procedure, the subject device disassembled in the patient's cavity.It is unknown how the subject device was retrieved from the patient's cavity or if there was a procedural delay due to this issue.Additional information is being requested of the customer.
Additional Manufacturer Narrative
The suspect device has not been returned to olympus for evaluation.The investigation is in process.Additional 510k, k931995.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 7 years since the subject device was manufactured.The product for this event was not returned for evaluation/inspection; therefore, this investigation was based solely upon the information provided by the customer.Additional information has been requested regarding this event.It is unclear if all pieces have been removed from the patient, nor is it known if an additional procedure would be required to remove any remaining fragments.However, there was no report of any patient harm.Based on the results of the investigation, a definitive root cause could not be established.The suggested phenomenon was presumed to have been due to mechanical thermal influence (thermal mechanical overload), based upon the described damage pattern; also, improper handling, mechanical impact like a fall, shock, or similar stress were presumed as factors.Finally, war and tear was also presumed as a contributing cause of the event.However, these presumed causes cannot be further determined - it is unknown whether there was previous damage on the device or any damage on the ceramic insulating insert that may have been caused during last reprocessing or during last usage.The instructions for use (ifu) carries a warning that the ceramic tip can break due to mechanical loading or thermally induced straining.Thus, it is the responsibility of the user to inspect the instrument prior to every procedure.Olympus will continue to monitor field performance for this device.H3 other text : device not returned.
Additional Manufacturer Narrative
Additional information: e2, e3 (customer contact data updated via diligence).

• Brand Name: INNER SHEATH, FOR 26 FR. OUTER SHEATH, WITH A22085A
• Common Device Name: ENDOSCOPE SHEATH, REUSABLE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14497873
• Report Number: 8010047-2022-08867
• Device Sequence Number: 17424216
• Product Code: HIH
• UDI-Device Identifier: 04042761029360
• UDI-Public: 04042761029360
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: A22040T
• Device Catalogue Number: A22040T
• Device Lot Number: 18YW-0021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2022
• Supplement Date Received by Manufacturer: 06/03/2022; 07/08/2022
• Initial Report FDA Received Date: 05/25/2022
• Supplement Report FDA Received Date: 07/01/2022; 07/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2018
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown