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 Date 08/23/2018

Event Type  malfunction  

Manufacturer Narrative

The referenced hf cable was not returned to olympus for evaluation.The cause of reported event could not be confirmed at this time.However, based on similar reports related to the device the cause of the reported event can most likely be attributed to improper handling, overload by application of external bending and/or stress by the user in combination with exceeded service life.The instruction manual provides warning in an attempt to mitigate the risk of injury to patient and user which states, ¿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 the middle of transurethral resection of a prostate procedure, the user facility reported a loud popping sound was heard and a small spark and smoke was observed came from the hf cable.There were only a few minutes of delay in the procedure as the resectoscope set was replaced and the intended procedure was completed without issue.The user facility reported they inspected the hf cable following the procedure and noted a small pin hole in the gray colored insulation just below the strain relief of the straight connector to the working element, wa22306d.The equipment was inspected prior to the procedure with no anomalies observed.There was no bleeding to the patient as a result of the reported event.The patient did not require a longer stay and did not require additional treatment.The user facility, did not believe there was any issue with the working element or the generator but will be sending the three devices for evaluation.

• 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: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355124
• MDR Report Key: 7887592
• MDR Text Key: 120734348
• Report Number: 2951238-2018-00550
• 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: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/18/2018

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: 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: 08/24/2018
• Initial Date FDA Received: 09/18/2018
• 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