MAUDE Adverse Event Report: CONMED LARGO POWERPRO ELECTRIC II MODULAR HANDPIECE; ARTHROSCOPE

Catalog Number PRO6100

Device Problem Self-Activation or Keying (1557)

Patient Problem Laceration(s) (1946)

Event Type  Injury  

Event Description

The customer reported that the device, pro6100, powerpro electric ii modular handpiece, was being used during an unknown procedure on an unknown date when it was reported, ¿the motor started up without pressing the trigger.As the trigger was fitted with an a0 bit and a drill, the handpiece injured the surgeon.For your information, all ao tips have been tested without any problems.¿.Further assessment questioning was asked, and the reporter stated, ¿the wick got caught in the surgeon's glove and went haywire.The surgeon was cut." there was no report of medical intervention or hospitalization for the user.There was no report of injury, medical intervention, of hospitalization for the user.The procedure was completed as planned.This report is being raised due to the reported injury of the surgeon being cut.

Manufacturer Narrative

The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.We will continue to monitor for trends through the complaint system to assure patient safety.H3 other text : device not yet received.

Manufacturer Narrative

The device was not overdue for preventative maintenance.No deficiency was noted with the operation of the device; however, the device did have moisture incursion from seal failure.The device was serviced, repaired, and met all specifications.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.The service history was reviewed, and no data was found.A two-year review of complaint history revealed there has been a total of two complaints, regarding two devices, for this device family and failure mode.During this same time frame 742 devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be 0.003.Per the instructions for use, the user is advised the following: handle all equipment carefully.If any equipment is dropped or damaged in any way, return it immediately for service.The user is also advised to perform the required preoperative functional tests for the equipment and accessories prior to each use.Additionally, the ifu continues gently shake the equipment free of water and wipe the surfaces with a clean, lint-free towel.We will continue to monitor for trends through the complaint system to assure patient safety.

Event Description

The customer reported that the device, pro6100, powerpro electric ii modular handpiece, was being used during an unknown procedure on an unknown date when it was reported, ¿the motor started up without pressing the trigger.As the trigger was fitted with an a0 bit and a drill, the handpiece injured the surgeon.For your information, all ao tips have been tested without any problems.¿.Further assessment questioning was asked, and the reporter stated, ¿the wick got caught in the surgeon's glove and went haywire.The surgeon was cut.".There was no report of medical intervention or hospitalization for the user.There was no report of injury, medical intervention, of hospitalization for the user.The procedure was completed as planned.This report is being raised due to the reported injury of the surgeon being cut.

Manufacturer Narrative

Additional information, update 13nov23: the probable cause for the customer's ¿unconfirmed¿ reported ¿handpiece running without trigger activated¿ was probably due to the confirmed moisture intrusion from seal failures leading to ¿intermittent electronic signal failures in the handpiece." the device was not overdue for preventative maintenance.No deficiency was noted with the operation of the device; however, the device did have moisture incursion from seal failure.The device was serviced, repaired, and met all specifications.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.The service history was reviewed, and no data was found.(b)(4).Per the instructions for use, the user is advised the following: handle all equipment carefully.If any equipment is dropped or damaged in any way, return it immediately for service.The user is also advised to perform the required preoperative functional tests for the equipment and accessories prior to each use.Additionally, the ifu continues gently shake the equipment free of water and wipe the surfaces with a clean, lint-free towel.We will continue to monitor for trends through the complaint system to assure patient safety.

Event Description

The customer reported that the device, pro6100, powerpro electric ii modular handpiece, was being used during an unknown procedure on an unknown date when it was reported, ¿the motor started up without pressing the trigger.As the trigger was fitted with an a0 bit and a drill, the handpiece injured the surgeon.For your information, all ao tips have been tested without any problems.¿.Further assessment questioning was asked, and the reporter stated, ¿the wick got caught in the surgeon's glove and went haywire.The surgeon was cut.".There was no report of medical intervention or hospitalization for the user.There was no report of injury, medical intervention, of hospitalization for the user.The procedure was completed as planned.This report is being raised due to the reported injury of the surgeon being cut.

• Brand Name: POWERPRO ELECTRIC II MODULAR HANDPIECE
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer (Section G): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer Contact: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 17197589
• MDR Text Key: 317814569
• Report Number: 1017294-2023-00057
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K981269
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PRO6100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2022
• Is the Device Single Use?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Ethnicity: Non Hispanic