MAUDE Adverse Event Report: CONMED UNIVERSAL HOSE, 10 FT; DRILL HOSE, SURGICAL

Catalog Number 00505201000

Device Problem Leak/Splash (1354)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

The reported devices are being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the devices evaluation and complaint investigation.

Event Description

The conmed sales representative reported on behalf of the user facility that post open heart surgery, the patient had an infection.During the procedure a 00505201000 universal hose was used.The device was reported to be leaking liquid and gas from where the handpiece was connected to the reported hose.The customer is unsure if the leak contributed to the infection.Although multiple attempts have been made, to date, no additional patient status or procedure information has been made available.This report is raised on the basis of a reported patient infection.

Manufacturer Narrative

The used device was returned to conmed for evaluation.Visual inspection of the device found some of the device's etching was missing.This device was 3rd party repaired, and non-conforming parts were found in the device, including a pressure line and pressure ferrules.This device was manufactured on february 26, 2015.The service history of this device was reviewed and no previous history or repairs were found.Preventative maintenance was overdue for this device.A review of the manufacturing documents verified the device was produced per current and approved procedures and material specifications.Non-conformances regarding the product's identity, quality, safety, effectiveness or performance were not identified at the time of manufacture.A review of this lot number showed no other complaint for this lot product and event description.A two-year review of complaint history revealed 11 other similar complaints for this product family and failure mode.There have been no other adverse events for this device family and failure mode combination.The reported concomitant device (universal hose, catalog number: 00505201000, lot: 781175) was also returned to conmed for evaluation.Visual inspection of the device found the pressure ferrule loose, leaks at the diffuser side and the exhaust hose has a pin hole at the diffuser side.This device was reportedly 3rd party repaired.The concomitant device was manufactured on october 2016.The service history of this device was reviewed and no previous history or repairs were found.Preventative maintenance was overdue for this device.The instructions for use advises the user of the following.Prior to each use, perform the following: o inspect all equipment for proper operation.O always inspect hoses for signs of wear or damage.Do not use worn or damaged hoses.Replace immediately.O check all equipment for any leakage.If leakage is noticed, return for service.No user service recommended.Refer servicing to qualified conmed linvatec service personnel.Do not oil or lubricate any of these products.While cleaning, do not immerse any equipment in fluids.While cleaning, keep hoses attached to the handpiece.Recommended care and handling of this equipment includes proper day-to-day operation and cleaning, which are extremely important to ensure safe and efficient operation.Prior to use, inspect all pneumatic equipment and hoses for signs of wear or damage.To ensure proper functioning and reduce the risk of a burst hose, do not use worn or damaged hoses, and immediately replace any hose with signs of wear or damage.Your authorized conmed linvatec service department is the most knowledgeable about this equipment and will provide competent and efficient service and repair.Any services and/or repairs done by an unauthorized repair facility may result in reduce performance of the instruments or instrument failure.Due to the severity of this reported patient injury, an investigation has been initiated.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: UNIVERSAL HOSE, 10 FT
• Type of Device: DRILL HOSE, SURGICAL
• Manufacturer (Section D): CONMED; 11311 concept blvd.; largo FL 33773
• MDR Report Key: 7456231
• MDR Text Key: 106396453
• Report Number: 1017294-2018-00056
• Device Sequence Number: 1
• Product Code: BYX
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 06/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2018
• 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: 628834
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CAT. 00505201000, LOT 781175, UNIVERSAL HOSE
• Patient Outcome(s): Other