MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-CABLE, BIPOLAR; CABLES/LEADS, ELECTROSURGICAL UNIT

Model Number WA00014A

Device Problems Break (1069); Sparking (2595)

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

Event Date 06/14/2023

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to olympus for evaluation.The investigation is ongoing.A supplemental report will be submitted if any additional information is provided.

Event Description

The customer reported that on jun 15th, before doing an unspecified therapeutic procedure, it was found the cable had broken.The procedure was completed with a similar device and no delay was reported.There was no report of harm.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and correction to d5.The device history record was unable to be reviewed for this device since the serial 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 investigation, it is likely that the event occurred due to wear and tear due to frequent use in connection with repeated great bending and/or tensile loads (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).The event can be prevented by following the instructions for use (ifu) which state: "firstly, the service life of the cable is limited to 12 months.After this period, the cable should no longer be used.Secondly, 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.Finally, 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.

• Brand Name: HF-CABLE, BIPOLAR
• Type of Device: CABLES/LEADS, ELECTROSURGICAL UNIT
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17568710
• MDR Text Key: 322213493
• Report Number: 9610773-2023-02275
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 04042761076449
• UDI-Public: 04042761076449
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K120418
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2023
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/10/2023
• 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: Initial
• Patient Sequence Number: 1