MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-CABLE, MONOPOLAR; HI-Q HAND INSTRUMENTS- UROLOGY

Model Number A0393

Device Problems Material Separation (1562); Smoking (1585)

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

Event Date 07/19/2022

Event Type  malfunction  

Manufacturer Narrative

The device was thrown out and cannot be inspected.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.

Event Description

The customer contacted olympus to report the electrosurgical unit (esu) cord from the resectoscope had become damaged during a prostate resection procedure.There was a loud pop heard and it was discovered that the esu cord had severed from the insertion point into the instrument.A small burn hole was noted in the drape, and there was a small puff of smoke.There was no burn to either patient or surgeon.The procedure was successfully completed with a similar device.There was no injury reported.

Manufacturer Narrative

Investigation activities have been opened to manage the actions related to this report and any required mdr reporting.This report is being supplemented to provide a correction to d4.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation.Please see updates to d4, d9, h3, h4, h6 and h10.The suspect device has been returned to olympus for evaluation and the device evaluation is in process.Based on the results of the investigation, it¿s likely the reported event (cord severed/small burn hole in the drape/small puff of smoke) was due to wear and tear.It was determined that the cable may be damaged by strong mechanical stress occurring from regular use, for example by kinking the cable, winding it in a radius that is too small or by pulling on the cable instead of the plug.This may cause individual or all wires in the cable to break, which may result in the reported event.In order to reduce the occurrence of this error pattern, the period of use of the cable was limited to 12 months.However, a final root cause of this event was unable to be identified.The following is included in the instructions for use: ¿the service life of the cable is limited to 12 months.After this time, the cable should no longer be used.Additionally, the cable must be checked for damage before each use and after reprocessing.By gently pulling on the plug (max.20n), it can be determined whether the copper strand of the cable is already damaged.If the cable does not give way but remains rigid, the cable is most likely intact.In order not to shorten the service life of the cable any further, the cable should not be wound up with a loop diameter of less than 10cm and when pulling out the cable, the plug should be pulled and not the cable.¿ olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.The device was returned to olympus for inspection, and the customer's complaint was confirmed.The hf-cable was not returned in its original packaging.The hf-cable was damaged and detached near the plug connector with the contact pin.The damaged portions of the cable were examined under a microscope, and it was observed that there were burnt and charred wires.Additionally, it was observed that the insulation was burnt and slightly melted.The rest of the hf-cable was inspected, there was no other cuts, tears, or kinks on the cable.The connectors appear to have no signs of physical damage or signs of burnt marks on the plugs.Functional testing of the cable was not performed due to the cable being damaged.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 5 years since the subject device was manufactured.Based on the results of the investigation, it¿s likely the reported event (cord severed/small burn hole in the drape/small puff of smoke) was due to wear and tear in connection with improper handling.The cable may become damaged by strong mechanical stress occurring from regular use, for example by kinking the cable, winding it in a radius that is too small or by pulling on the cable instead of the plug.This may cause individual or all wires in the cable to break, which may result in the reported event.In order to reduce the occurrence of this error pattern, the period of use of the cable is limited to 12 months.However, a final root cause of this event was unable to be identified.The following is included in the instructions for use: "the service life of the cable is limited to 12 months.After this time, the cable should no longer be used.Additionally, the cable must be checked for damage before each use and after reprocessing.By gently pulling on the plug (max.20n), it can be determined whether the copper strand of the cable is already damaged.If the cable does not give way but remains rigid, the cable is most likely intact.In order not to shorten the service life of the cable any further, the cable should not be wound up with a loop diameter of less than 10cm and when pulling out the cable, the plug should be pulled and not the cable.¿ olympus will continue to monitor field performance for this device.

• Brand Name: HF-CABLE, MONOPOLAR
• Type of Device: HI-Q HAND INSTRUMENTS- UROLOGY
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662
• MDR Report Key: 15491109
• MDR Text Key: 306321006
• Report Number: 9610773-2022-00438
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04042761001656
• UDI-Public: 04042761001656
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K944201
• 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,Followup,Followup,Followup
• Report Date: 01/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A0393
• Device Catalogue Number: A0393
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2017
• 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