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

Model Number	A22040T
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing; therefore, the root cause of the reported malfunction cannot be determined at this time.However, if additional information becomes available, this report will be supplemented accordingly.
Event or Problem Description
The technical support engineer was informed by the user facility that the ceramic tip from the inner sheath reportedly became lost inside the patient during an unspecified procedure.The staff was able to retrieve the tip with no harm to the patient and the procedure was completed.The lot number on the sheath was unknown because it was illegible.No device will be returned.
Event or Problem Description
The certified surgical technologist at the user facility further reported the malfunction occurred during the middle of an unspecified procedure.While the patient was under general anesthesia, there was a half hour delay as another device was obtained and used to complete the intended procedure.No device will be returned for evaluation.
Additional Manufacturer Narrative
This supplemental report was submitted to provide additional information from the user facility and to update the following sections: a3, b5, d9, e2, e3, g2, g3, g6, h2, h6 and h10.
Additional Manufacturer Narrative
This supplemental report was submitted to provide additional information from the original equipment manufacturer and to update the following sections: g3, g6, h2, h6 and h10.A device history record review could not be performed as the lot number is unknown.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 investigation was completed by the oem and determined that there is no manufacturing, material or processing related cause for this failure mode.The concerned device was not returned for evaluation; therefore, the root cause of the reported event cannot be conclusively determined.However, as for the technical cause, the damage of the insulation material of the sheath was potentially caused by thermal mechanical overload, improper handling, mechanical impact like fall, shock or similar stress.Please note that signs of fatigue or pre-damage, such as minute cracks, are often hard to spot.The oem will continue to monitor complaints for this device.

• Brand Name: INNER SHEATH, FOR 26 FR. OUTER SHEATH, WITH A22085A
• Common Device Name: INNER SHEATH
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 12215242
• Report Number: 9610773-2021-00205
• Device Sequence Number: 4742852
• Product Code: HIH
• UDI-Device Identifier: 04042761029360
• UDI-Public: 04042761029360
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/12/2021

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: 06/30/2021
• Supplement Date Received by Manufacturer: 07/28/2021; 08/03/2021
• Initial Report FDA Received Date: 07/22/2021
• Supplement Report FDA Received Date: 07/28/2021; 08/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1