MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH OLYMPUS PLASMALOOP- MEDIUM, 12-30 DEGREE; ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

Model Number @9052945

Device Problem Break (1069)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/14/2022

Event Type  malfunction  

Event Description

During procedure, transurethral resection of bladder neck contracture, the loop broke in the cavity and tore the prostate.Fda safety report id # (b)(4).

• Brand Name: OLYMPUS PLASMALOOP- MEDIUM, 12-30 DEGREE
• Type of Device: ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; hamburg 22045 DE; GM 22045 DE
• MDR Report Key: 14236435
• MDR Text Key: 290387906
• Report Number: MW5109416
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 14042761085356
• UDI-Public: (01)14042761085356
• 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: 04/26/2022

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 Model Number: @9052945
• Device Catalogue Number: WA22706S
• Device Lot Number: 1000087453
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/27/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 76 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American