MAUDE Adverse Event Report: GYRUS ACMI, INC. CUTTING LOOP (12/PK); ENDOSCOPIC ELECTROSURGICAL ELECTRODE, MONOPOLAR, SINGLE-USE

Model Number MLE-24-012

Device Problem Connection Problem (2900)

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

Event Date 11/21/2022

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report has been returned to olympus.The evaluation has not yet been completed.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Event Description

The customer reports during an unspecified procedure using a cutting loop, the cutting loop would not meet connection to cord in working element.The user had to open another.There was no risk to staff or patient.The procedure was prolonged long enough to get new equipment with no further consequences to the patient reported.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.Device evaluation found the visual inspection with no abnormality or thermal damage on the loop, and the shaft is straight.There was one extra brass crimp connector on the shaft proximal end; therefore, the device now has two connectors instead of one as it should be.Minor scratches were found on its surface.In addition, the device was able to produce energy output during further testing.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the reported event was caused by an extra brass crimp got stuck on the proximal end of the electrode which could have caused fitting issue.The following information is stated in the instructions for use (ifu): "no modification of this device/equipment is allowed.Modification of this device/equipment may result in injury to the patient and/or operator, and damage to the equipment and/or peripheral instruments.This device has no serviceable parts." correction: the manufacturer has determined there is no potential for this issue of the cutting loop not connecting to the cord in the working element to cause or contribute to an adverse event.

• Brand Name: CUTTING LOOP (12/PK)
• Type of Device: ENDOSCOPIC ELECTROSURGICAL ELECTRODE, MONOPOLAR, SINGLE-USE
• Manufacturer (Section D): GYRUS ACMI, INC.; 800 west park drive; westborough MA 01581
• Manufacturer (Section G): GYRUS ACMI, INC.; 800 west park drive; westborough MA 01581
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16028016
• MDR Text Key: 308205427
• Report Number: 3003790304-2022-00349
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K890328
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MLE-24-012
• Device Lot Number: KR234751
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1