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 Information (3190)

Event Date 11/15/2018

Event Type  malfunction  

Manufacturer Narrative

The hf cable was not returned to olympus and is currently being held by the facility¿s quality department.The cause of the reported event could not be determined at this time.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.Additionally, the oem performed a manufacturing and quality control review for the affected lot number without showing any non-conformities or deviations during the manufacturing of the device.

Event Description

Olympus was informed that during a therapeutic transurethral resection of the prostate (turp) procedure, the user heard a pop noise and the hf cable sparked off the element.There were no flames observed and the room was not evacuated.The user facility reported that it is unknown if the connection block was securely connected.There were no alarms or alerts noted on the generator.The generator settings were preset: ¿plasma turp¿ saline cut 200/saline coag 120.The intended procedure was completed with a similar device.Additionally, the user facility reported that this cord was in service less than a year.

• 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
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355124
• MDR Report Key: 8167080
• MDR Text Key: 131383589
• Report Number: 2951238-2018-00762
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 04042761076449
• UDI-Public: 04042761076449
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120418
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2018
• 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: 17ZW-9593
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 78 YR