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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was not returned to olympus for evaluation.A definitive root cause for this issue was not established.However, it is probable the damage of the insulation material of the sheath was caused by thermal mechanical overload, improper handling, mechanical impact like fall, shock, or similar stress.Also, it cannot be determined with certainty, whether there was a previous damage on the device or any damage on the ceramic insulating insert was caused during last reprocessing or during last usage.Note that the cause of the reported issues is attributed to wear and tear.The cause of the faded laser inscription was likely due to frequent reprocessing.The lot/serial number for the subject device could not be obtained due to the faded laser inscription, therefore, a dhr review couldn't be performed.The instruction for use provides the following warning before use: ¿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.
Event or Problem Description
An olympus sales rep reported on behalf of the customer, ceramic tip of inner sheath for 26fr.Outer sheath with a22085a broke off in patient.The intended procedure was a therapeutic cystoscopy.There was a delay in procedure when medical staff irrigated the patient for retrieval of broken pieces.All pieces were placed together to form a complete tip.The procedure was completed using a similar device.There was no report of patient harm associated with this event.The laser inscription was faded; therefore, the lot number is unknown.

• 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, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 15848374
• Report Number: 9610773-2022-00559
• Device Sequence Number: 14731664
• Product Code: HIH
• UDI-Device Identifier: 04042761029360
• UDI-Public: 04042761029360
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/22/2022

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: A22040T
• Device Catalogue Number: A22040T
• Device Lot Number: UNKNOWN
• 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: 10/26/2022
• Initial Report FDA Received Date: 11/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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