MAUDE Adverse Event Report: OLYMPUS CORPORATION OF THE AMERICAS OLYMPUS RESECTOSCOPE 24 FR RESECTION SHEATH; RESECTOSCOPE, WORKING ELEMENT

Catalog Number A22041A

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/07/2022

Event Type  malfunction  

Event Description

On (b)(6) 2022, during a cystoscopy with bladder biopsy, a foreign body was retrieved from the anterior portion of the prostate fossa.Upon examination it appeared to be the beak of a resectoscope, foreign body was sent to pathology which confirmed it was consistent with the beak of a resectoscope.The patient previously had a cystoscopy with transurethral resection of the prostate and bladder tumor on (b)(6) 2022.A resectoscope was used during this procedure and it is believed the beak tip broke off of the inner sheath of the resectoscope during that time.

• Brand Name: OLYMPUS RESECTOSCOPE 24 FR RESECTION SHEATH
• Type of Device: RESECTOSCOPE, WORKING ELEMENT
• Manufacturer (Section D): OLYMPUS CORPORATION OF THE AMERICAS; san jose CA
• MDR Report Key: 16067543
• MDR Text Key: 306354999
• Report Number: MW5114040
• Device Sequence Number: 1
• Product Code: FDC
• 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: 12/22/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: A22041A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/27/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 101 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White