MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-CABLE, BIPOLAR; ELECTROSUGRICAL RESECTION AND VAPORIZATION ELECTRODE SERIES

Model Number WA00014A

Device Problem Electro-Static Discharge (2149)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/26/2023

Event Type  malfunction  

Event Description

The customer reported to olympus that the hf-cable, bipolar had an electric arc between two cable attachment pin on the resectoscope.The issue was found during the prostate operation procedure, which was completed with a similar device.There were no reports of patient harm.Related patient identifiers are as follows: (b)(6).

Manufacturer Narrative

The device was returned to olympus for evaluation, and the customer¿s allegation was confirmed.The evaluation found the following reportable issues: the plug for the instruments is completely detached causing the electric arc issue.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 3 years since the subject device was manufactured.Based on the results of the investigation, it is likely that the following led to the malfunction: the cause is most likely improper handling by the user, in combination with wear and tear.The event can be detected and prevented by following the instructions for use which state: the service life of high frequency cables is restricted to one year.Furthermore, the cable must be inspected before and after each use and reprocessing cycle.This can be done by slightly pulling the plug to identify if wires inside the cable are pre-damaged (a force with 20 newtons at most shall be used when pulling the plug).When the cable remains rigid and does not bend, this area of the cable is very likely faultless.Additionally, the cable shall be wound up with a diameter of less than 10 cm.When removing the cable, the plug shall be pulled and not the cable.No other issues were found at evaluation.Olympus will continue to monitor field performance for this device.

• Brand Name: HF-CABLE, BIPOLAR
• Type of Device: ELECTROSUGRICAL RESECTION AND VAPORIZATION ELECTRODE SERIES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18323169
• MDR Text Key: 330954509
• Report Number: 9610773-2023-03617
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 04042761076449
• UDI-Public: 04042761076449
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K120418
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/13/2023

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 Lot Number: 208W-4101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/27/2023
• Initial Date FDA Received: 12/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2020
• 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