MAUDE Adverse Event Report: CONMED MICROCHOICE OSC SAW

Catalog Number 00502002400

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/26/2017

Event Type  Injury  

Manufacturer Narrative

Despite several attempts to obtain the reported device, this device has not been returned to conmed for evaluation. Photographs were requested and, to date, none have been received. This incident cannot be verified and a root cause cannot be determined. The serial number provided was invalid, therefore, manufacturing documents were unable to be reviewed. A two-year review of complaint history revealed 7 similar reports for this product family. In that same timeframe, (b)(4) devices have been manufactured and shipped worldwide. It is standard medical practice to inspect and test all equipment before use. This incident type will continue to be monitored through the complaint system to assure patient safety.

Manufacturer Narrative

The reported device is currently undergoing proper supply chain procedures but is expected to be returned to conmed for evaluation. A supplemental and final report will be filed after the device evaluation and complaint investigation are complete.

Event Description

The user facility reported that while the surgeon was using the oscillating handpiece the scrub nurse assembled, he noticed the blade was coming loose. When he pulled it out of the patients' mouth, during a multi-part oral reconstruction procedure, it was noted that multiple pieces of the device were detached. He retrieved parts of the device from the patients' mouth but when he tried to account for all pieces, two could not be located. A x-ray revealed one piece which the surgeon retrieved, however, the second piece was not accounted for. The surgeon performed a bronchoscopy to ensure the missing piece was not in the lungs. No patient injury was reported and the procedure was completed with more than a thirty minute delay. This report is raised on the basis of a device malfunction with an unlocated device component, which led to surgical intervention causing a lengthy procedural delay. This incident is being reported as an adverse event.

• Brand Name: MICROCHOICE OSC SAW
• Type of Device: MICROCHOICE OSC SAW
• Manufacturer (Section D): CONMED; 11311 concept blvd; largo FL 33773
• Manufacturer (Section G): CONMED CORPORATION; 525 french road; utica NY 13502
• Manufacturer Contact: lindsey sheppard ; 525 french road; utica, NY 13502 ; 7273995209
• MDR Report Key: 6960758
• MDR Text Key: 253244270
• Report Number: 1017294-2017-00110
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K072706
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 12/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 00502002400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 12/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 10/19/2017 Patient Sequence Number: 1