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

Model Number WA22702S

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 03/10/2021

Event Type  malfunction  

Event Description

"while using the olympus plasma loop during a transurethral resection of a bladder tumor, the loop split when it came in contact with the brachytherapy seeds, which were still in the patient from his former brachytherapy.Surgeon was present and aware of the incident.Surgeon stated that it was to be expected when the tur (transurethral resection) loop comes in contact with brachytherapy seeds.The loop in its entirety was removed from the patient.No part of the tur loop was broken off of the device.A new tur loop was opened and used for the remainder of the procedure.Brachytherapy seeds were sent to pathology for gross id.No brachytherapy seeds were broken by either of the tur loops." no patient harm.

• Brand Name: HF-RESECTION ELECTRODE PLASMALOOP
• Type of Device: ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; 118 turnpike road; southborough MA 01772
• MDR Report Key: 11526850
• MDR Text Key: 241007221
• Report Number: 11526850
• 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: 03/12/2021

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
• Device Operator: No Information
• Device Model Number: WA22702S
• Device Catalogue Number: WA22702S
• Device Lot Number: 1000066995
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/12/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/19/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/19/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27375 DA