MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE "PLASMA-OVALBUTTON"; ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

Model Number WA22766S

Device Problem Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/12/2022

Event Type  malfunction  

Event Description

No access to med record.Per team the loop on the device was defective.A new device needed to be obtained for the procedure.

• Brand Name: HF-RESECTION ELECTRODE "PLASMA-OVALBUTTON"
• Type of Device: ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; 800 west park drive; westborough MA 01581
• MDR Report Key: 16277347
• MDR Text Key: 308564919
• Report Number: 16277347
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/17/2022

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: WA22766S
• Device Catalogue Number: WA22766S
• Device Lot Number: 1000097079
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/17/2022
• Event Location: Hospital
• Date Report to Manufacturer: 02/01/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/01/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1