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

Model Number WA22606S

Device Problems Break (1069); Mechanical Problem (1384)

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

Event Date 01/18/2023

Event Type  malfunction  

Manufacturer Narrative

The subject device was not returned for evaluation.The cause of the issue is unknown at this time.In addition multiple follow ups were made to gather additional information, however, were unsuccessful as no response is received.Supplemental report(s) will be submitted should any relevant new information is available and or received.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Event Description

Olympus received a medsun (b)(4) report with an event/ problem reported of "while resecting prostate during a transurethral resection prostate surgery the loop electrode got caught while in the patient on a urolift clip and the loop broke into 2 pieces both pieces.No harm to patient.The bipolar transurethral resection of prostate was completed.No harm was reported.No patient harm, no user injury reported.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it is likely that the event occurred due to excessive force by the customer.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This report is being supplemented to provide additional information based on customer response to follow up.Communication with the customer the following information conveyed: no error messages observed during the event.None reported.Procedure was a bipolar transurethral resection of prostate and was completed.No harm to the patient.Customer stated they do not have the device.No further information was provided.Investigation is ongoing.This report will be supplemented accordingly following investigation.

• Brand Name: HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, MEDIUM, 24 FR., 12°-30°, PK TURIS
• Type of Device: HF-RESECTION ELECTRODE "PLASMALOOP
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16519965
• MDR Text Key: 311508798
• Report Number: 9610773-2023-00714
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 14042761085158
• UDI-Public: 14042761085158
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171965
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date: 06/30/2023

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: WA22606S
• Device Catalogue Number: WA22606S
• Device Lot Number: 1000102362
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/10/2023
• Initial Date FDA Received: 03/10/2023
• Supplement Dates Manufacturer Received: 03/15/2023; 06/07/2023
• Supplement Dates FDA Received: 04/11/2023; 06/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UROLIFT CLIP
• Patient Age: 63 YR
• Patient Sex: Female