MAUDE Adverse Event Report: CONMED LARGO UNIVERSAL HOSE, 10 FT; TUBING, PRESSURE AND ACCESSORIES

Catalog Number 00505201000

Device Problem Burst Container or Vessel (1074)

Patient Problem Insufficient Information (4580)

Event Date 04/27/2023

Event Type  Injury  

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.

Event Description

The customer reported that the device, 00505201000, universal hose, 10 ft, was being used during a hallux valgus procedure on (b)(6) 2023 when it was reported, ¿during the operation, the hose burst and there were brown debris outside the pipe.Operating field was no longer sterile, neither the table.Discontinuation of the surgery.Operating room has to be cleaned for further patient.Surgery re-schedule for the day after with agreement from the patient.¿ there was no report of injury to the patient or user; however, it was reported that hospitalization was prolonged another day and that the patient was given antibiotics and the surgical site was decontaminated twice.Further assessment information has been requested; however, to date we have not received a response.The pro6150, powerpro pneumatic modular handpiece, was being used with the hose and will be listed as the concomitant device as no malfunction was reported of this device.This report is being raised due to the reported injury of ¿brown debris¿ contaminating field and surgical site decontamination required for the patient, as well as prolonged hospitalization for secondary procedure.

Event Description

The customer reported that the device, 00505201000, universal hose, 10 ft, was being used during a hallux valgus procedure on (b)(6) 2023 when it was reported, ¿during the operation, the hose burst and there were brown debris outside the pipe.Operating field was no longer sterile, neither the table.Discontinuation of the surgery.Operating room has to be cleaned for further patient.Surgery re-schedule for the day after with agreement from the patient.¿ there was no report of injury to the patient or user; however, it was reported that hospitalization was prolonged another day and that the patient was given antibiotics and the surgical site was decontaminated twice.Further assessment information has been requested; however, to date we have not received a response.The pro6150, powerpro pneumatic modular handpiece, was being used with the hose and will be listed as the concomitant device as no malfunction was reported of this device.This report is being raised due to the reported injury of ¿brown debris¿ contaminating field and surgical site decontamination required for the patient, as well as prolonged hospitalization for secondary procedure.

Manufacturer Narrative

The customer reported the event against a conmed device originally, however, upon receipt it was discovered that the device associated with this event is not a conmed product.Therefore, a preliminary investigation cannot be conducted.Device not manufactured by conmed, unable to complete device history record review, lot history review or risk analysis.Unknown who manufactured the device; therefore, conmed was unable to contact the correct manufacturer.We will continue to monitor for trends through the complaint system to assure patient safety.

• Brand Name: UNIVERSAL HOSE, 10 FT
• Type of Device: TUBING, PRESSURE AND ACCESSORIES
• 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: 16930696
• MDR Text Key: 315206341
• Report Number: 1017294-2023-00043
• Device Sequence Number: 1
• Product Code: BYX
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 07/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 00505201000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Patient Sequence Number: 1
• Treatment: PRO6150, POWERPRO PNEUMATIC MODULAR HP
• Patient Outcome(s): Other; Required Intervention; Hospitalization
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic