MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF CABLE, BIPOLAR, 4 M, FOR ESG-400 SALINE MODE; ELECTROSURGICAL RESECTION AND VAPORIZATION

Model Number WA00014A

Device Problem Sparking (2595)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/24/2019

Event Type  malfunction  

Manufacturer Narrative

The reference device was not returned to service center for a evaluation.The cause of the reported event could not be confirmed at this time.As no lot or serial number was made available, a 24 month review of production records was performed.No deviations or reworks related to the reported device issue were noted.However, based on similar reports, the most probable cause of the reported event could be attributed to improper handling, overload by application of external bending and/or unintended stress by the user in combination with exceeded service life.The instructional manual provides warning to mitigate the risk of injury to the patient and/ or user which states, 'reprocessing and mechanical stress damages the hf cable'.If the device is returned at a later date, this report will be supplemented accordingly.

Event Description

The service center was informed that during a therapeutic transurethral resection of the prostate (turp) procedure, the cable sparked and then broke in the middle of procedure.No patient injury reported.The intended procedure was completed with a similar device.No other equipment was replaced during procedure.

Manufacturer Narrative

The hf cable was returned to the service center for evaluation for the reported ¿cable sparked and then broke in the middle of procedure.¿ a visual inspection was performed on the received condition and found the straight plug connector was detached from the hf cable just below the boot of the straight plug connector.The breaking point was inspected under a microscope; burn marks was observed.A functional test could not be conducted due to the separated hf cable.Based on the results, it was likely the hf cable was initially damaged and partially separated from the straight connector plug prior to procedure, although not completely detached.Upon activation, due to insufficient conductive material, the portion of the wire that was open and separated produced an electrical arc due to the close proximity of the two connections combined with the high power and frequency of the output energy of the generator, resulting in the ¿sparked¿ users¿ experience.As per the instruction manual, ¿always pull at the plug to disconnect the hf cable from the hf unit and working element.Never pull at the cable.¿ additionally, ¿reprocessing and mechanical stress damages the hf cable.After the first use, the hf cable has a service life of 12 months.Dispose of the hf cable after 12 months.¿.

Event Description

The device was inspected prior to the procedure and no anomalies found.There were no damages noted on the device.Procedure was prolonged by approx.5mins.Also, no bleeding, no longer stay, no intervention, no additional treatment was provided to the patient due to the event.Patient's current condition is healthy.Esg-400 and resectoscope used with the referenced device during the procedure.

• Brand Name: HF CABLE, BIPOLAR, 4 M, FOR ESG-400 SALINE MODE
• Type of Device: ELECTROSURGICAL RESECTION AND VAPORIZATION
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 8812249
• MDR Text Key: 151747967
• Report Number: 9610773-2019-00089
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 04042761076449
• UDI-Public: 04042761076449
• Combination Product (y/n): N
• PMA/PMN Number: K120418
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/31/2019

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: WA00014A
• Device Catalogue Number: WA00014A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/24/2019
• Initial Date FDA Received: 07/22/2019
• Supplement Dates Manufacturer Received: 07/23/2019; 09/30/2019
• Supplement Dates FDA Received: 07/23/2019; 10/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1