MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF CABLE, BIPOLAR, 4 M, FOR ESG-400

Model Number WA00014A

Device Problems Break (1069); Sparking (2595)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/09/2017

Event Type  malfunction  

Manufacturer Narrative

The hf cable was not returned for evaluation.The cause of the reported event could not be determined at this time.However, to mitigate the risk of device damage, the instruction manual provides warnings that states ¿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 the device is returned for evaluation at a later date, this report will be supplemented accordingly.

Event Description

Olympus was informed that during a transurethral resection of the prostate procedure, the hf cable sparked and broke.The bipolar hf cable sparked and broke at the right angle plug that connects to the working element.The procedure was completed using a monopolar devices.No injury to the patient or user was reported.In addition, the hf cable was inspected prior to procedure with no anomalies observed.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information from the original equipment manufacturers (oem).The oem conducted a review of the device history records (dhr) for the concerned lot number which revealed there were no abnormalities/non-conformities during the manufacturing process.

Manufacturer Narrative

This supplemental report is being submitted to provide the device evaluation results.A visual inspection confirmed the right angle plug of the hf cable was detached with evidence of burn marks at the breakage point and internal elements of the hf cable.Functional testing could not be performed due to condition of the hf cable.In addition the blue connector to the hf unit is cracked/chipped with a missing piece.

• Brand Name: HF CABLE, BIPOLAR, 4 M, FOR ESG-400
• Type of Device: HF CABLE, BIPOLAR, 4 M, FOR ESG-400
• 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: 7052956
• MDR Text Key: 93479428
• Report Number: 2951238-2017-00743
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/11/2018

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: Physician
• Device Model Number: WA00014A
• Device Catalogue Number: WA00014A
• Device Lot Number: 14ZW-3349
• Other Device ID Number: 04042761076449
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/09/2017
• Initial Date FDA Received: 11/22/2017
• Supplement Dates Manufacturer Received: 12/22/2017; 01/11/2018
• Supplement Dates FDA Received: 01/10/2018; 01/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2014
• 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