MAUDE Adverse Event Report: GYRUS ACMI, INC CUTTING LOOP (12/PK)

Model Number MLE-24-015

Device Problems Break (1069); Sparking (2595)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/20/2019

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to olympus for evaluation.The cause of the reported event cannot be conclusively determined; however, the instruction manual warns users ¿failure to properly follow the instructions, warnings, and cautions may lead to serious surgical consequences or injury to the patient and/or surgical team.Misuse of instruments can cause injury to the patient and/or surgical team and could have an adverse effect on the procedure being performed.Do not drop instruments, or allow them to be struck by other objects.¿.

Event Description

Olympus was informed therapeutic turbt procedure, the loop cracked/sparked during a case causing damage to end of scope and the resectoscope to melt.The electrode broke while the doctor was resecting the tumor and the user facility believes that the electrode may have touched something metal, as the end of the cystoscope melted.No portion of the electrode fell into the patient, but it blew the end of the resectoscope off.The resectoscope fragment was retrieved with graspers.No bleeding reported due to the incident.No alarms or errors displayed on the generator.The generator settings were 100cut/ 85coag.They used a new loop and instrumentation to complete the procedure.The procedure was prolonged by about 10 minutes.No longer stay or additional procedures needed.There was no patient injury reported.Additionally, the electrode and cord was inspected before use with no anomalies found.This is 1 of 2 reports.

Manufacturer Narrative

This supplemental report is being submitted to report the additional information.Please the updates in sections: h2, h3, h6 and h10.The package-level (mle-24-015 mk785237) and device-level (98-0498-121-1 sf745775) dhrs for this product have been reviewed.All records indicate that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.To date the electrode was not returned for evaluation.Based on similar reports, the reported spark was likely a result of user technique as the customer reported, "the electrode may have touched something metal, as the end of the cystoscope melted." note, this is a monopolar device meaning that the return electrode must be properly positioned on the patient and all endoscopic instruments accessories and energy sources are properly grounded to avoid damage to the instruments or injury to the patient.The device ifu (99-1082 rev be) states, "this is a monopolar device.Make sure the patient return electrode (grounding plate) is properly positioned on the patient and connected to the electrosurgical generator.When endoscopic instruments, accessories and electromedical energy sources from different manufacturers are used together, verify that any isolation or ground is not violated.".

• Brand Name: CUTTING LOOP (12/PK)
• Type of Device: CUTTING LOOP (12/PK)
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 8530146
• MDR Text Key: 142485340
• Report Number: 2951238-2019-00750
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• PMA/PMN Number: K890328
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 09/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MLE-24-015
• Device Lot Number: MK785237
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACMI ENDOSCOPE M3-30A; ACMI RESECTOSCOPE ERIS-CF27; MEGADYNE MEGAPOWER #2,