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 Known Impact Or Consequence To Patient (2692)

Event Date 06/18/2019

Event Type  malfunction  

Manufacturer Narrative

The hf cable and handpiece will not be returned to the service center as both pieces were discarded by the user facility after the procedure.The instruction manual states in the ¿warning risk of injury to patient and user¿ section that ¿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.In addition the ¿inspect the hf cable visually ¿section of the ifu states ¿inspect the entire hf cable.Do not use a hf cable with brittle or defective insulation.Replace the hf cable if necessary.¿.

Event Description

The service center was informed that during an unspecified procedure, the hf cable sparked.It was reported that the user waited a few minutes and then connected a new hf cable and hand piece to the generator.The intended procedure was completed.There was no 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 22045 ; GM 22045
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662
• MDR Report Key: 8801120
• MDR Text Key: 151870790
• Report Number: 9610773-2019-00080
• 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,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 07/17/2019

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/19/2019
• Initial Date FDA Received: 07/17/2019
• 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