MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, MEDIUM, 24 FR., 12°/16°, ESG TURIS; ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE-USE

Model Number WA22702S

Device Problem Sparking (2595)

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

Event Date 10/27/2022

Event Type  malfunction  

Manufacturer Narrative

The suspect device was not sent to olympus for evaluation.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.

Event Description

The customer reported the device caused an electric spark during an unspecified procedure.A second device was attempted with the same result.The procedure was completed with a third similar device.Additional details have been requested regarding the reported event.At this time, no additional information has been provided.There was no harm or user injury reported due to the event.This report is for the second device.The first device is being reported on the medwatch with patient identifier (b)(4).

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.The device was not returned for evaluation.However, based on the results of the investigation, it¿s likely the electric spark occurred due to user error, as it¿s probable the wrong combination of the products led to the breakage of the distal end of the electrode.The root cause of this event was unable to be identified.Olympus will continue to monitor field performance for this device.

• Brand Name: HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, MEDIUM, 24 FR., 12°/16°, ESG TURIS
• Type of Device: ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE-USE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; 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: 16274848
• MDR Text Key: 308645706
• Report Number: 9610773-2023-00391
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 14042761085325
• UDI-Public: 14042761085325
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/21/2023

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: WA22702S
• Device Catalogue Number: WA22702S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/27/2022
• Initial Date FDA Received: 01/31/2023
• Supplement Dates Manufacturer Received: 03/24/2023
• Supplement Dates FDA Received: 04/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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