MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH OLYMPUS ESG-100, 100...120 V~,; ELECTROSURGICAL GENERATOR

Model Number WB991046

Device Problem Output above Specifications (1432)

Patient Problem Burn(s) (1757)

Event Type  Injury  

Manufacturer Narrative

An investigation to obtain additional information regarding the reported event is ongoing.The esg-100 generator with serial# (b)(4) was returned for evaluation due to "delivered too much energy, overheated snare.¿ the customer's snare and footswitch were not returned with the generator.A visual inspection was performed on the returned generator and found dents on the rear sides of the top cover.The top cover was removed to inspect the printed circuit boards and noted a burn mark on the r28 resistor of the esg-100 sa communication board due to normal wear; however, this did not affect the power output or contribute to the reported complaint.Further investigation verified that there was a communication between esg and the test afu-100.When the special button or toggle (a middle button of the test footswitch) was pressed, the pump flow functioned normally.The generator was checked with a test metron electrosurgery analyzer, and passed all the output power inspection.The front panel, contact quality monitor, bipolar and monopolar connectors all functioned properly.In addition, the customer's settings of monopolar forcecoag 2 with power level 10w was also checked with the analyzer, and load resistance was set at 500 ohms.This generated the measured power output at 10w which appeared to be consistent with setting power level.The customer¿s complaint of ¿too much output¿ was not confirmed.The exact cause of the reported event cannot be determined at this time.The legal manufacturer will review the content of this report for further investigation.However, the esg 100 instruction manual provides several warnings to prevent patient/user burns.The instruction manual states as follows: burns: warning patient and / or user: the maximum output voltage characteristics of the electrosurgical unit are shown in the diagrams in chapter 12.2 (output characteristics).When setting the power level, first set it to a low level and increase it gradually.If the output is initially set to a high level, the electrode¿s insulation may be damaged and cause user and / or patient burns.However, certain modes may present an unacceptable risk at low output power settings.For example, with the pulsecut fast or pulsecut slow mode, the risk of an excessive thermal effect rises if the output power setting is too low.Therefore, it is recommended that you perform basic testing before using the electrosurgical unit.If the instructions for use of the endoscopic instrument to be used stipulate a rated voltage, the output should be set so that it does not exceed that voltage.Contact with the tip of the electrodes may cause burns when the electrosurgical unit is active.Warning, output performance: should any abnormal output be suspected during operation, immediately terminate the use of the equipment by releasing the footswitch.If the footswitch does not react, switch off the electrosurgical unit.Otherwise, malfunction of the equipment may cause an unintended increase in output.Warning: before each use, inspect this unit as instructed below.Inspect other equipment to be used with this unit as instructed in their respective instructions for use.Should the slightest irregularity be suspected, do not use the electrosurgical unit and refer to chapter 9 (troubleshooting).If the irregularity is still suspected after consulting chapter 9, contact olympus or your distributor.Damage or irregularity may compromise patient or user safety and may result in more severe equipment damage.This event has been reported by the importer on mdr# 2951238-2020-00496.

Event Description

The service center was informed that during an unspecified procedure, the generator delivered too much energy to the snare and the patient sustained an internal burn.The user facility reported that the tip of the snare was burnt.The generator settings used were 10 watts and 2 coag.It is unknown if the intended procedure was completed.The patient¿s course of treatment is unknown.

Manufacturer Narrative

This supplemental report is being submitted to provide the lm investigation.The legal manufacturer (lm) reviewed the content of this complaint for further investigation.The legal manufacturer reported that the root cause could not be determined.A manufacturing and quality control review was performed for the affected serial number without showing any non-conformities or deviations regarding the described issues.The product was sold on: 07.11.2012.The lm reported that the most probable causes for the reported event are as follows: since the reported esg-100 was evaluated to be in standard, a technical malfunction of the generator can be ruled out as the cause of the reported patient injury.However, a defective hand instrument or improper handling by the user can cause the instrument to overheat, possibly leading to tissue burns.The deformation of the top cover can most likely be attributed to improper handling by the customer.The discolorations at the communication board, which were probably caused by heat generation, were traced back to wear and tear.The sbc evaluated both the deformation of the top cover and the discolorations at the communication board as in standard.There are no countermeasures necessary, because no error could be reproduced and the device meets its specification.The legal manufacturer will monitor the occurrence rate in the context of our quality management system.If necessary, the legal manufacturer will take action in the future.

• Brand Name: OLYMPUS ESG-100, 100...120 V~,
• Type of Device: ELECTROSURGICAL GENERATOR
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• MDR Report Key: 10587673
• MDR Text Key: 212297873
• Report Number: 9610773-2020-00223
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04042768910463
• UDI-Public: 04042768910463
• Combination Product (y/n): N
• PMA/PMN Number: K073207
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 01/25/2021

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: WB991046
• Device Catalogue Number: WB991046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/31/2020
• Initial Date FDA Received: 09/25/2020
• Supplement Dates Manufacturer Received: 12/30/2020
• Supplement Dates FDA Received: 01/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SNARE (MODEL/LOT# UNK)
• Patient Outcome(s): Other