MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF UNIT "ESG-400"; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number WB91051W

Device Problem Grounding Malfunction (1271)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report has not yet been fully evaluated by olympus.The definitive cause of the user's experience cannot be determined at this time.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Event Description

It is reported that a physician verbalized refusal to use a hf generator.The physician stated concern that multiple error codes were experienced with the device during one procedure, however olympus has been unable to replicate the issue the last two times the device has been sent in for evaluation.The physician further reported that a patient "almost died" due this issue.Multiple attempts have been made to gather additional information regarding this reported patient/procedure with no response.An olympus representative who was in contact with the facility in october at the time the multiple codes were initially reported as occurring during one procedure states that there was no mention of any patient adverse event at the time of the initial report.

Manufacturer Narrative

This report is being submitted to report investigation findings.Physical evaluation of the complaint device reveals: olympus carried out a safety inspection.All test parameters were within the permitted range.The generator was therefore evaluated to be in standard.Device history review (dhr): a manufacturing and quality control review was performed for the affected lot or serial number without showing any non-conformities or deviations regarding the described issue.Conclusion: it is unclear what caused the customer¿s issues.Since the generator is evidently in standard the reported issues can most likely be attributed to a user error.Error message e202 is triggered if the resistance between the two electrodes of a split-type electrode is too high.A maximum of 140 ohms is permissible.The appearance of error message e202 does not represent a defect of the generator but is rather designed to alert the user that the neutral electrode needs to be checked.This is a ¿warning¿ which is part of the safety concept of the esg-400.

• Brand Name: HF UNIT "ESG-400"
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• MDR Report Key: 11068750
• MDR Text Key: 227215002
• Report Number: 9610773-2020-00303
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04042761076838
• UDI-Public: 04042761076838
• Combination Product (y/n): N
• PMA/PMN Number: K141225
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WB91051W
• Device Catalogue Number: WB91051W
• Device Lot Number: B001035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1