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 Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The referenced hf cable was not returned to olympus for evaluation.Olympus followed up with the user facility via telephone and in writing to obtain additional information regarding the reported event but with no result.The exact cause of the reported event could not be conclusively determined.However, based on similar reported events, reprocessing of the cable, mechanical stress, and fluid invasion likely contributed to the reported event.The instruction manual contains several warning statements in an effort to prevent damage to the cable.¿visually inspect the entire hf-cable.Do not use a hf-cable with a brittle or defective insulation.Replace the hf cable if necessary due to reprocessing and mechanical stress damage.After the first use, the hf cable has a service life of 12 months.Dispose of the hf cable after 12 months.Additionally, the oem performed a review of the device history records (dhr) for the referenced lot number and revealed no deviations regarding the function and safety of the cable.If the device is returned to evaluation at a later date, this report will be updated accordingly.

Event Description

Olympus was informed that during an unspecified procedure, the hf cable sparked after being connected to the generator.It is unknown if the intended procedure was completed.There was no user or patient injury reported.

• 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 22045 ; GM 22045
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 408935-512
• MDR Report Key: 6983558
• MDR Text Key: 91120094
• Report Number: 2951238-2017-00708
• 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: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 10/27/2017

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: 14ZW-3283
• Other Device ID Number: 04042761076449
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/10/2017
• Initial Date FDA Received: 10/27/2017
• 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