MAUDE Adverse Event Report: OLYMPUS WINTER IBE GMBH OLYMPUS; ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

Model Number WA22606S

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 10/15/2021

Event Type  malfunction  

Event Description

During cysto, using the olympus bipolar loop for cauterizing the bladder.The loop was opened and connected to gyrus machine.The device did not work properly.It is believed that the disposable loops are at fault.There may be more than one lot involved.Olympus was informed.

• Brand Name: OLYMPUS
• Type of Device: ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
• Manufacturer (Section D): OLYMPUS WINTER IBE GMBH; 118 turnpike road; southborough MA 01772
• MDR Report Key: 12810636
• MDR Text Key: 280759750
• Report Number: 12810636
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 14042761085158
• UDI-Public: (01)14042761085158
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WA22606S
• Device Catalogue Number: WA22606S
• Device Lot Number: 1000071919
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/18/2021
• Event Location: Hospital
• Date Report to Manufacturer: 11/15/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 28470 DA
• Patient Sex: Male