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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONMED MICROCHOICE RECIPROCATING SAW

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CONMED MICROCHOICE RECIPROCATING SAW Back to Search Results
Catalog Number 00502002300
Device Problem Detachment Of Device Component (1104)
Patient Problem No Code Available (3191)
Event Date 03/13/2018
Event Type  Injury  
Manufacturer Narrative
The used headpiece, without the reported blade, was returned to conmed for evaluation. Visual inspection and use testing with an alternate blade found that the blade cannot remain secure in the collet due to a broken saw mechanism. The saw mechanism remained attached to the microchoice handpiece. Manufacture recommendation for preventative maintenance for this device is every 12 months. A service history review found this device was overdue for maintenance with the last preventative maintenance performed on february 29, 2012. To date, although multiple attempts have been made, additional information regarding the patient and procedure has not been made available. A two-year review of complaint history revealed 9 other similar complaints for this product family and failure mode. A risk analysis was performed and found this failure mode and occurrence level to be consistent and acceptable with risk documents. The instructions for use advises the user of the following. Micropower handpieces and attachments shall be returned every 12 months for servicing. It is good medical practice to inspect and/or test equipment prior to use. This issue will continue to be monitored through the complaint system to assure patient safety.
 
Event Description
The conmed sales representative reported on behalf of the user facility that during a maxfax procedure, the 00502002300 reciprocating saw detached from the handpiece. This led to "a fair bit of trauma" to the patient. The facility did not have an alternate device, so the procedure was postponed to the next day. To date, no additional information regarding patient status or procedure has been made available. This report is being raised on the basis of a reported patient injury.
 
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Brand NameMICROCHOICE RECIPROCATING SAW
Type of DeviceMICROCHOICE RECIPROCATING SAW
Manufacturer (Section D)
CONMED
11311 concept blvd.
largo FL 33773
Manufacturer (Section G)
CONMED CORPORATION
525 french road
utica NY 13502
Manufacturer Contact
martha camacho urribarri
525 french road
utica, NY 13502
3156243051
MDR Report Key7426030
MDR Text Key105311793
Report Number1017294-2018-00048
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K072706
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 04/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number00502002300
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/28/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/19/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2006
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 04/12/2018 Patient Sequence Number: 1
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