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

Model Number WA00014A

Device Problems Electrical /Electronic Property Problem (1198); Failure to Deliver Energy (1211); Output Problem (3005)

Patient Problem No Code Available (3191)

Event Date 01/10/2018

Event Type  Injury  

Manufacturer Narrative

The suspect medical device has not yet been returned to the manufacturer for evaluation/investigation.Therefore, the exact cause of the user's experience and the reported phenomenon could not be determined and is being judged as unknown.However, if the suspect medical device is returned for evaluation/investigation or additional significant information becomes available, this report will be updated.

Event Description

Olympus was informed that during a therapeutic transurethral resection of the prostate (turp) procedure, the esg-400 electrosurgical generator suddenly stopped working and an error code was displayed, indicating a problem with the hf cable.Since no spare equipment was available, the procedure had to be interrupted for 1 to 2 hours until another hf cable was provided.Then, the intended procedure was successfully completed and there was no report about actual patient injury.

Manufacturer Narrative

The suspect medical device was not returned to the manufacturer for evaluation/investigation but to olympus medical systems corporation (omsc), (b)(4) (returned to omsc on 2018-01-31).When the hf cable was inspected and tested, it was found to be in good working order and in accordance with its specifications.No abnormality, defect, failure or malfunction was found during the performance tests.Furthermore, a material or quality problem can be excluded since a manufacturing and quality control review was performed for the affected lot number of the hf cable without showing any abnormalities.Therefore, the exact cause of the user's experience and the reported phenomenon could not be determined and is being judged as unknown.The case will be closed from olympus side with no further actions.However, the reported event/incident will be recorded for trending and surveillance purposes.

• Brand Name: HF CABLE, BIPOLAR, 4 M, FOR ESG-400 SALINE MODE
• Type of Device: HF-CABLES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• MDR Report Key: 7240677
• MDR Text Key: 99000436
• Report Number: 9610773-2018-00009
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• PMA/PMN Number: PK120418
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 02/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: WA00014A
• Device Catalogue Number: WA00014A
• Device Lot Number: 132W
• Other Device ID Number: 04042761076449
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/10/2018
• Initial Date FDA Received: 02/05/2018
• Supplement Dates Manufacturer Received: 02/09/2018
• Supplement Dates FDA Received: 02/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OLYMPUS HF UNIT "ESG-400" (WB91051J); OLYMPUS HF UNIT "ESG-400" (WB91051J)
• Patient Outcome(s): Required Intervention
• Patient Age: 91 YR