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

Model Number WB91051W

Device Problem Defective Component (2292)

Patient Problems Blood Loss (2597); Dysuria (2684)

Event Date 05/14/2020

Event Type  Injury  

Manufacturer Narrative

The device was returned to the service center, evaluated and repaired.The high frequency generator board was determined to be defective.A deeper investigation of generator boards related to error e433 showed that a destroyed transformer tr1 caused this issue.An improved generator board for the affected device was introduced in the middle of july 2020.A direct connection between the cause of the reported injury and the cause of error message e433 cannot be established, since the generator does not deliver any energy after the error message occurs.Therefore, the cause is very likely due to user error.The e433 error is activated by the device¿s safety system, which triggers the device to restart.If the error cause persists, an unlimited number of periodic restarts can be triggered.Clinical/medical assessment: there are several possible reasons for the described injury (i.E.Blood in urine).The following complications may occur: organs and structures nearby can be injured.This can result in harm to the bladder, bladder sphincter and urethra.As a result, the patient might experience uncontrolled urine leakage (i.E.Incontinence) or urethral narrowing.Bleeding and secondary bleeding are also possible.If the bladder wall is penetrated, injuries can also occur to internal organs such as the intestine or uterus, and serious peritonitis can occur.Inflammation, increased scarring, and wound healing disorders may occur.Device history record review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.Olympus will continue to monitor complaints for this device.

Event Description

It was reported that during a transurethral resection of the prostate (turp), the unit produced a high priority error message (e433).The procedure was completed with another device.The procedure was delayed as a result of the error message issue and took approximately three hours and twenty minutes.It was later identified that the patient experienced difficulty urinating and bleeding while urinating.The patient was hospitalized and a procedure to address the urination issue was to be scheduled.Additional information is unavailable at this time.

Manufacturer Narrative

This report is being supplemented to provide the legal manufacturer¿s investigation summary regarding this report and additional information regarding the patient/event (reported in b5).Since the device for this complaint was not returned to olympus, the investigation is based solely on the information provided by the customer.A direct connection between the cause of the reported injury and the cause of error message cannot be established, since the generator does not deliver any energy after the error message occurs.Therefore, the cause is very likely due to user error.The reported error message is triggered by the safety system of the esg-400 and communicated visually and acoustically to the user.It is part of the device's own security system.In critical cases, further use of the device is prevented by the security system until the error has been corrected.The customer is required to check the function of all devices used prior to procedure.In addition, according to the ifu, a suitable replacement device must be provided during use.The reported error is activated by the device¿s safety system, which triggers the device to restart.If the error cause persists, an unlimited number of periodic restarts can be triggered.Possible causes include: the user activates the foot switch while the generator is booting up (temporary fault caused by user action).A defective foot switch (temporary error).A defective foot switch (temporary error, defective reed contact).A defective cable connection between hvps board and generator board (temporary or permanent error).A defective hvps board (permanent error).A defective generator board (permanent error).In this case, the error was caused by a faulty generator board.There are several possible reasons for the described patient injury (i.E.Blood in urine).The following complications may occur: organs and structures nearby can be injured.This can result in harm to the bladder, bladder sphincter and urethra.As a result, the patient might experience uncontrolled urine leakage (i.E.Incontinence) or urethral narrowing.Bleeding and secondary bleeding are also possible.If the bladder wall is penetrated, injuries can also occur to internal organs such as the intestine or uterus, and serious peritonitis can occur.Inflammation, increased scarring, and wound healing disorders may occur.

Event Description

Additional information was provided (b)(6) 2020:the patient underwent an unspecified procedure to address the reported adverse events.The issues are now resolved.The patient was hospitalized for more than 3 days.The customer attributes the adverse events experienced by the patient to the complaint device.

• 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: 10550556
• MDR Text Key: 210691978
• Report Number: 9610773-2020-00217
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 10/22/2020

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: WB91051W
• Device Catalogue Number: WB91051W
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/14/2020
• Initial Date FDA Received: 09/17/2020
• Supplement Dates Manufacturer Received: 09/30/2020
• Supplement Dates FDA Received: 10/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention