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

Model Number	WA22606S
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/15/2021
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
• Manufacturer (Section D): OLYMPUS WINTER IBE GMBH; 118 turnpike road; southborough MA 01772
• MDR Report Key: 12810636
• Report Number: 12810636
• Device Sequence Number: 20220819
• Product Code: FAS
• UDI-Device Identifier: 14042761085158
• UDI-Public: (01)14042761085158
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/18/2021
• Report Date (Section F): 10/18/2021

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
• Operator of Device: 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
• Event Location: Hospital
• Date Report to Manufacturer: 11/15/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/15/2021
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Date Report Sent to FDA: 10/18/2021