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

Model Number WA22606S

Device Problem Failure to Power Up (1476)

Patient Problem Insufficient Information (4580)

Event Date 11/07/2022

Event Type  malfunction  

Event Description

Product would not cauterize tissue.Writer unplugged and re-plugged in device, surgeon stepped on pedal multiple times to activate device.Writer got new product; product worked just fine without any other issues.

• Brand Name: OLYMPUS
• Type of Device: ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; 800 west park drive; westborough MA 01581
• MDR Report Key: 16408843
• MDR Text Key: 309895538
• Report Number: 16408843
• Device Sequence Number: 1
• Product Code: FAS
• 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: 11/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2023
• 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/07/2022
• Event Location: Hospital
• Date Report to Manufacturer: 02/21/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 28105 DA
• Patient Sex: Female