MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH RESECTOSCOPE SHEATH 24FR

Model Number A22040A

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 12/02/2020

Event Type  malfunction  

Event Description

During the case while doing turbt (transurethral resection of bladder tumor)(blue light) the surgeon suddenly noticed a piece of gray foreign body inside the bladder, through the lens he noted a broken tip of the of the 24 fr resectoscope sheath (a22040a).Surgeon removed the broken piece (piece by piece) using an alligator forceps.Scrub nurse and charge nurse checked the pieces making sure it is complete.Surgeon made sure that he removed the remaining pieces so that there's nothing left in the bladder.Instrument was removed from the tray, tagged and sent to sterile processing department (spd).

• Brand Name: RESECTOSCOPE SHEATH 24FR
• Type of Device: RESECTOSCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; 118 turnpike road; southborough MA 01772
• MDR Report Key: 11093605
• MDR Text Key: 224311243
• Report Number: 11093605
• Device Sequence Number: 1
• Product Code: FJL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/14/2020

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
• Device Operator: Health Professional
• Device Model Number: A22040A
• Device Catalogue Number: A22040A
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/14/2020
• Event Location: Hospital
• Date Report to Manufacturer: 12/30/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25915 DA