MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-CABLE, BIPOLAR; ELECTRICAL-ONLY MEDICAL DEVICE CONNECTION CABLE, REUSABLE

Model Number WA00014A

Device Problem Sparking (2595)

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

Event Date 02/20/2023

Event Type  malfunction  

Event Description

There was no alleged complaint reported by the customer for the subject device.The wa22367a (working element, passive, for resection in saline) was returned to an olympus service center for evaluation with a report of ¿sparks appearing at the diathermy connection end.¿ upon inspection and testing of the returned device (wa22367a), the reported issue was not confirmed.Olympus suspected that the reported issue was attributed to a faulty hf cable (wa00014a).This report is being submitted for the reportable malfunction of sparks.There was no patient or user injury reported due to the event.

Manufacturer Narrative

This mdr is being submitted as part of a retrospective review and remediation effort based on enhancements made to the company¿s mdr and complaint handling processes.Capas have been opened to manage the actions that are being taken to remediate this issue and ensure any required mdr reporting is completed.H4 device manufacturer date: date of manufacture cannot be determined since the lot number was not provided.The subject device was not returned to an olympus service center for evaluation.The device history record was unable to be reviewed for this device since the lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the legal manufacturer's investigation, it is likely that the cable was damaged by strong mechanical stress during use, e.G.If the user kinks the cable, winds it up with a radius that is too small, or pulls on the cable instead of the connector.This may cause individual or all wires inside the cable to break.When the generator is activated, this may lead to a voltage flashover in the damaged area, which most likely resulted in the reported sparks.The damage is most likely attributable to age-related wear and tear in connection with improper handling by the user.However, a definitive root cause could not be identified.In order to prevent this issue, the user should follow the instructions which can be found in the ifu (instructions for use): - the service life of the cable is limited to 12 months.After this period, the cable should no longer be used.- the cable needs to be checked for damage prior to each use and after reprocessing.By slightly pulling on the connector (with a maximum of 20 n), the user can determine if there is pre-existing damage to the stranded copper wire of the cable.If the cable does not yield but remains rigid, the cable is most likely fine at this place.- in order not to reduce the service life of the cable further, the cable should not be wound up with a loop diameter of less than 10 cm, and the user should pull on the connector and not on the cable when unplugging the cable.Olympus will continue to monitor field performance for this device.H3 other text : device not returned.

• Brand Name: HF-CABLE, BIPOLAR
• Type of Device: ELECTRICAL-ONLY MEDICAL DEVICE CONNECTION CABLE, REUSABLE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, germany 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: 17290605
• MDR Text Key: 319480811
• Report Number: 9610773-2023-01833
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 04042761076449
• UDI-Public: 04042761076449
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K120418
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2023
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/26/2023
• 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