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

Model Number A22040A

Device Problems Break (1069); Device Fell (4014)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/01/2022

Event Type  Injury  

Event Description

The customer reports during a cystoscopy and transurethral resection of a bladder tumor (turbt) for the indication of bladder tumor using a 26fr sheath, the tip of the sheath broke off and fell into the patient¿s bladder.The procedure had just begun, the resectoscope was being used for approx.2-3 min when the device broke.The device fragments fell into the patient's bladder and were retrieved with forceps.The patient did not experience any adverse effects related to this occurrence.The patient's current condition is described as: the patient was not harmed; the biopsy was preformed, and the patient was transferred to pacu and to home in stable condition.There were no anatomical or procedural challenges that could have contributed to the device breaking.

• Brand Name: INNER SHEATH, FOR 26 FR. OUTER SHEATH
• Type of Device: RESECTOSCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• MDR Report Key: 15885219
• MDR Text Key: 304509740
• Report Number: 2429304-2022-00142
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04042761029339
• UDI-Public: 04042761029339
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/02/2022,11/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A22040A
• Device Catalogue Number: A22040A
• Device Lot Number: 17XW-0149
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/02/2022
• Event Location: Hospital
• Date Report to Manufacturer: 11/02/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 79 KG