MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY SUCTION COAG, F/S, 10FR, 25/CS; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	130187
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2023
Type of Reportable Event	Malfunction
Additional 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.
Event or Problem Description
This complaint arises from the receipt of medwatch uf/importer report # (b)(4), in which a customer reported that the 130187, suction coag, f/s, 10fr, 25/cs device was being used during an adenoidectomy procedure on (b)(6) 2023, and ¿conmed 10fr suction bovie piece of plastic broke off completely and was temporarily lost.Repeat bronch and confirmed that no plastic was left in the patient¿s airway.The piece was later found in the suction line.¿.Further assessment confirmed that the ¿repeat bronch¿ occurred during the same reported event; there was not a second procedure.The procedure was completed and there was no injury, medical/surgical intervention for patient or user, and no extended hospital stay for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Event or Problem Description
This complaint arises from the receipt of medwatch uf/importer report # (b)(4), in which a customer reported that the 130187, suction coag, f/s, 10fr, 25/cs device was being used during an adenoidectomy procedure on (b)(6) 2023, and "conmed 10fr suction bovie piece of plastic broke off completely and was temporarily lost.Repeat bronch and confirmed that no plastic was left in the patient's airway.The piece was later found in the suction line." further assessment confirmed that the "repeat bronch" occurred during the same reported event; there was not a second procedure.The procedure was completed and there was no injury, medical/surgical intervention for patient or user, and no extended hospital stay for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Additional information: medwatch uf/importer report # (b)(4) was received from the fda on 06feb24; this is a duplicate of medwatch uf/importer report # (b)(4) received from fda on 12jan24.Received one 130187 in unoriginal package.Lot number was not verified.Performed a visual inspection, the device came back completely dissembled.Root cause cannot be determined, however, based upon the ifu; a possible cause of this event could be that the item was not thoroughly inspected before use.A device history record (dhr) review found a non-conformance, however, it was not related to the reported event.This is the only such occurrence for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of two reports, regarding two devices, for this device family and failure mode.During this same time frame (b)(4) 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 (b)(4).Per the instructions for use, the user is advised: these devices should never be used when there is visible evidence of damage to the exterior of the device such as cuts, punctures, nicks, abrasions, unusual lumps, or significant discoloration.We will continue to monitor for trends through the complaint system to assure patient safety.

• Brand Name: SUCTION COAG, F/S, 10FR, 25/CS
• Common Device Name: 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: beth madeline ; 11311 concept blvd; largo, FL 33773 ; 7274708358
• MDR Report Key: 18581043
• Report Number: 3007305485-2024-00020
• Device Sequence Number: 18204502
• Product Code: GEI
• UDI-Device Identifier: 30653405059930
• UDI-Public: (01)30653405059930(17)270804(10)202208059
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K033003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 130187
• Device Lot Number: 202208059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2024
• Supplement Date Received by Manufacturer: 02/16/2024
• Initial Report FDA Received Date: 01/25/2024
• Supplement Report FDA Received Date: 02/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic