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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONMED CORPORATION HALL 50 OSCILLATING SAW SAW, POWERED, AND ACCESSORIES

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CONMED CORPORATION HALL 50 OSCILLATING SAW SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number PRO7300B
Device Problems Material Separation (1562); Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/31/2020
Event Type  Malfunction  
Manufacturer Narrative

At time of filing, although expected, the reported device has not been returned to conmed for evaluation. A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation. This issue will continue to be monitored through the complaint system to assure patient safety.

 
Event Description

On behalf of the customer, the distributor reported issues involving the pro7300b, hall 50 oscillating saw, lot/ser # (b)(4) that occurred at (b)(6) hospital, (b)(6), on (b)(6) 2020. Information received was the issue occurred during a total knee replacement procedure involving a (b)(6) yr old female ((b)(6) kg). It is noted that after use, once the power tool was placed back on the table it was noticed that the right on/off switch was missing. Two items were found in the drapes, 1 washer and 1 on/off switch. It is also noted the procedure was successfully completed with a 30minute delay, no alternate device was used and there was no impact or injury to the patient. Additional clarification received indicates the saw had just been used on the patient, but no issues were noted at that time. The missing on/off switch was noticed only after the device was placed on the table. Although the washer and switch were found in the surgical drapes, it could not be confirmed that all pieces were accounted for thus an xray was taken the next day. Xray results were clear indicating no parts remained in the patient. This report is being raised on the basis of malfunction with potential for injury upon reoccurrence as an xray was necessary to ensure all parts were located.

 
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Brand NameHALL 50 OSCILLATING SAW
Type of DeviceSAW, POWERED, AND ACCESSORIES
Manufacturer (Section D)
CONMED CORPORATION
11311 concept blvd
largo, fl
Manufacturer (Section G)
CONMED CORPORATION
11311 concept blvd
largo FL 33773 4908
Manufacturer Contact
tracey weiselbenton
11311 concept blvd
largo, FL 33773-4908
7273995557
MDR Report Key10468760
MDR Text Key217425628
Report Number1017294-2020-00373
Device Sequence Number1
Product Code HAB
Combination Product (Y/N)N
Reporter Country CodeNZ
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/29/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/28/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberPRO7300B
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/28/2020
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/28/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/07/2019
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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