MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-CABLE, BIPOLAR, 4 M, TURIS/TCRIS RESECTOSC; ELECTROSURGICAL RESECTION AND VAPORIZATION

Model Number WA00014A

Device Problems Break (1069); Electrical Shorting (2926)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/22/2016

Event Type  malfunction  

Manufacturer Narrative

The hf-cable was not returned to olympus for evaluation.The root cause for the reported event cannot be determined; however, the most likely cause for the reported event can be attributed to mechanical stress and fluid invasion when the hf current was activated.The instructions manual contains warning statements in an effort to prevent damage to the cable."visually inspect the entire hf cable.Do not use a hf cable with brittle or defective insulation.Replace the hf cable if necessary.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

Olympus was informed that during a therapeutic bipolar resection procedure, the nurse heard a loud crack or snapping sound as the hf-cable and its tip blew off (separated) from the working element.The hf generator settings were cut 200/coag 120 with no error codes observed.The hf-cable was replaced and the intended procedure was completed.There was no patient injury.Additionally, the user facility reported that the cord, connection and other equipment were inspected prior to the procedure with no anomalies found.The user facility inspected the cord post procedure and no char or burn marks were observed.The user facility reported that it is possible that the cord may have been used passed the manufacture's recommended lifespan of 12 months.

Manufacturer Narrative

This supplemental report is being submitted to provide the device evaluation and to update the device lot number.The device was returned to olympus for evaluation.A visual inspection confirmed the straight plug was broken and charred stains were observed on the cable¿s internal wires at the distal end plug.The broken straight plug that attaches to the generator was not returned for evaluation.In addition, the hf cable unit was noted to be cut into three pieces and there was no evidence of physical damage on cable or the adapter.Due to the returned condition of the device no further testing could be performed on the cable.Based on similar reports, this type of cable damage can occur if the internal wires short out during hf activation causing sparking and arcing.

• Brand Name: HF-CABLE, BIPOLAR, 4 M, TURIS/TCRIS RESECTOSC
• 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: 6019525
• MDR Text Key: 57111308
• Report Number: 2951238-2016-00799
• 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,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2016
• 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: 13XW
• Other Device ID Number: 04042761076449
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: HF GENERATOR