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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP, INC. AESCULAP KERRISON RONGEUR, POWERED

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AESCULAP, INC. AESCULAP KERRISON RONGEUR, POWERED Back to Search Results
Model Number 281-061
Device Problems Material Separation (1562); Naturally Worn (2988)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/09/2017
Event Type  malfunction  
Event Description
At the beginning of the procedure, the kerrison #3 bone punch fell apart before use on the patient, and the screw was noted to be missing. The item was removed from service immediately after all pieces were collected. The mobile repair services inspected the instrument and determined that all pieces in fact were present. It is believed that the failure occurred due to normal wear and tear. The age of the item is approximately 15 years. The instrument was repaired by mobile repair tech and deemed appropriate for use. The item was permanently removed from service and new devices were ordered (b)(6). Manufacturer response for surgical instrument, aesculap kerrison (per site reporter). Mobile repair serves inspected the instrument and determined that all pieces were present. It is believed that this occurred from normal wear and tear. The approximate age of the device is 15 years. The instrument was repaired by the mobile repair tech and deemed appropriate to use. However, the item was permanently removed from service and new kerrison's were ordered (b)(6).
 
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Brand NameAESCULAP KERRISON
Type of DeviceRONGEUR, POWERED
Manufacturer (Section D)
AESCULAP, INC.
3773 corporate parkway
center valley PA 18034
MDR Report Key6854555
MDR Text Key85636385
Report Number6854555
Device Sequence Number1
Product Code HAD
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 08/25/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/11/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number281-061
Device Catalogue Number281-061
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/25/2017
Device Age15 YR
Event Location Hospital
Date Report to Manufacturer08/25/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 09/11/2017 Patient Sequence Number: 1
Treatment
UNKNOWN. THE PATIENT WAS UNDERGOING A L4 TO S1 LAM
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