MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY LAP PROBE,5 MM, H/SWITCH,36CM; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number 160636

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

The device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.A supplemental and final report will be filed following the completion of the complaint investigation.We will continue to monitor for trends through the complaint system to assure patient safety.

Event Description

The customer reported that the 160636, lap probe,5 mm, h/switch, 36cm device was being used during a laparoscopic cholecystectomy procedure on an unknown date when it was reported ¿we had an incident with conmed argon laparoscopic probe where it got melted and broken while using.¿ further assessment questioning found that ¿dr notified by scrub nurse and circulator plastic insulated sheath on abc device appeared to be missing portion of the plastic end piece when removed from patient abdomen conducted through visual search of patient surgical site.Dr unable to locate fragment.Suction irrigator in use.Procedure continued and completed as planned.¿.There was no report of medical intervention, or extended hospitalization for the patient or user.This report is being raised on the reported injury due to patient retaining a foreign body.

Event Description

The customer reported that the 160636, lap probe,5 mm, h/switch,36cm device was being used during a laparoscopic cholecystectomy procedure on an unknown date when it was reported ¿we had an incident with conmed argon laparoscopic probe where it got melted and broken while using.¿.Further assessment questioning found that ¿dr notified by scrub nurse and circulator plastic insulated sheath on abc device appeared to be missing portion of the plastic end piece when removed from patient abdomen conducted through visual search of patient surgical site.Dr unable to locate fragment.Suction irrigator in use.Procedure continued and completed as planned.¿.There was no report of medical intervention, or extended hospitalization for the patient or user.This report is being raised on the reported injury due to patient retaining a foreign body.

Manufacturer Narrative

The device has not been returned to date and no photographic evidence has been provided; therefore, the reported event cannot be verified.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.A two-year lot history review shows a total of 3 devices for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of 5 complaints, regarding 5 devices, for this device family and failure mode.(b)(4).Per the instructions for use, the user is advised to question unusual requests for increased power output settings.Such requests should initiate a check of integrity/condition of all cords, connections, and electrodes including the dispersive electrode (ground pad) before a power increase is made.We will continue to monitor for trends through the complaint system to assure patient safety.

• Brand Name: LAP PROBE,5 MM, H/SWITCH,36CM
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• Manufacturer (Section G): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• Manufacturer Contact: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 18075334
• MDR Text Key: 327483227
• Report Number: 3007305485-2023-00234
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 30653405003858
• UDI-Public: (01)30653405003858(17)280410(10)202304124
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K925903
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 160636
• Device Lot Number: 202304124
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2023
• Initial Date FDA Received: 11/06/2023
• Supplement Dates Manufacturer Received: 12/26/2023
• Supplement Dates FDA Received: 01/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2023
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Ethnicity: Non Hispanic