MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH OLYMPUS RESECTOSCOPE

Model Number A22041A

Patient Problems Hemorrhage/Bleeding (1888); Foreign Body In Patient (2687)

Event Date 10/10/2023

Event Type  Injury  

Event Description

During a transurethral resection of a bladder tumor, the plastic tip of the resectoscope broke off in the pt's bladder and was initially located.Once the surgeon addressed the bleeding and cauterized where the tumor was, he went back to find the plastic piece and it was no longer visible.Dr.Continued to look for the piece for a prolonged time, the drapes were checked, along with the floor and all surrounding areas around the patient and the piece was never located.Past medical history of bladder tumor, r ureteral stent.Pt gets serial cystoscopies for bladder tumors, surgeon will continue to search during repeat cystoscopies.

• Brand Name: OLYMPUS RESECTOSCOPE
• Type of Device: RESECTOSCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH
• MDR Report Key: 18072666
• MDR Text Key: 327389990
• Report Number: MW5147760
• Device Sequence Number: 1
• Product Code: FJL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A22041A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/03/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 88 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White