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 Problems Break (1069); Sparking (2595)

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

Event Date 09/20/2017

Event Type  malfunction  

Manufacturer Narrative

The hf cable was not returned to olympus for evaluation.Therefore the exact cause could not be determined at this time.The exact cause of the reported event could not be conclusively determined.However, the instruction manual contains warning statements in an effort to prevent damage to the cable, to visually inspect the entire hf-cable.Do not use a hf-cable with a brittle or defective insulation.Replace the hf cable if necessary.Also, reprocessing and mechanical stress damages to 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.If additional information becomes available or if the device is returned for evaluation at a later date, this report will be supplemented accordingly.Additionally, the oem performed a review of the device history records (dhr) for the concerned lot number and revealed no deviations or non-conformities were found during the manufacturing process.

Event Description

Olympus was informed that the hf cable sparked and became severed during an unspecified therapeutic procedure.The connector to the working element blew off the end of the cord.No other damage occurred to the other equipment.The intended procedure was completed using a similar hf cable.There was no patient injury reported.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information from the user facility.The reported event occurred during the middle of a transurethral resection of a prostate procedure (turp).No fire was observed during the procedure.The procedure was delayed by five minutes.The concomitant devices used during the procedure was a (wa22367a) working element and an (esg-400) electrosurgical generator that was preset to 200/140 settings.The subject hf cable was inspected prior to procedure with no anomalies observed.No other devices were replaced during the procedure.

Manufacturer Narrative

This supplemental report is being submitted to provide the device evaluation results.A visual inspection of the hf cable found the right angle plug was completely detached.The cable is separated just below the plug¿s protective boot cover.No other anomalies were noted with the hf cable.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information received from the user facility.On december 19, 2017, olympus received medwatch# (b)(4) which included patient information.The user facility also reported the correct procedure type was a (turbt) transurethral resection of a bladder tumor.

• 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, hamburg
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 408935-512
• MDR Report Key: 6927473
• MDR Text Key: 89738137
• Report Number: 2951238-2017-00672
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK120418
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: WA00014A
• Device Catalogue Number: WA00014A
• Device Lot Number: 168W-4131
• Other Device ID Number: 04042761076449
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2017
• 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: 73 YR