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

Model Number A22040A

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/29/2023

Event Type  Injury  

Event Description

It was reported, the tip of the subject device broke off and fell inside the patient during a therapeutic cystoscopy, placement of ureteral stent left, clot evacuation and fulguration procedure.Bleeding was controlled before moving to stent placement, and the procedure was completed without delay.The broken tip was discovered in the bladder and successfully retrieved when the patient underwent a therapeutic cystoscopy, laser enucleation prostate, left ureteroscopy with stone lithotripsy and stent procedure on (b)(6) 2024.There were no reports of further patient harm.

• Brand Name: INNER SHEATH, FOR 26 FR. OUTER SHEATH
• Type of Device: RIGID ENDOSCOPE SHEATH
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• MDR Report Key: 18791180
• MDR Text Key: 336361660
• Report Number: 2429304-2024-00125
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 02/09/2024,02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A22040A
• Device Lot Number: 18YW0448
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/09/2024
• Event Location: Hospital
• Date Report to Manufacturer: 02/09/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BUTTON 24FR 30DEG OVL HF-RES WA22766S ELECTRODE
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 85 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White