MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, MEDIUM, 24 FR., 12°-30°, ESG TURIS; ELECTRODES, ELECTROSURGICAL

Model Number WA22706S

Device Problem Break (1069)

Patient Problem Laceration(s) (1946)

Event Date 04/14/2022

Event Type  Injury  

Event Description

The customer reports during a transurethral resection of a bladder neck contracture using a plasma loop with an esg400 generator, the plasma loop broke and tore the prostate.The loop was not completely detached.One side of the loop was still attached, only one side was broken off.No device fragment fell off into the patient.It is unknown if there were any procedural or anatomical challenges that could have contributed to the loop breaking.There was no treatment/intervention required to treat the prostate tear.The patient's current condition is reported as "patient tolerated procedure well and sent to post anesthesia care unit (pacu) then home." the generator settings being used during the procedure were 220 saline cut and 120 saline coagulation.The generator did not malfunction in any way.

• Brand Name: HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, MEDIUM, 24 FR., 12°-30°, ESG TURIS
• Type of Device: ELECTRODES, ELECTROSURGICAL
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• MDR Report Key: 14771925
• MDR Text Key: 294501240
• Report Number: 2951238-2022-00436
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 14042761085356
• UDI-Public: 14042761085356
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/23/2022,06/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WA22706S
• Device Catalogue Number: WA22706S
• Device Lot Number: 1000087453
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/23/2022
• Event Location: Hospital
• Date Report to Manufacturer: 05/23/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/22/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ESG400, SN B010386
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 76 KG