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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG KAIRISON PNEUM.PUNCH HANDLE BONE PUNCHES, RONGEURS

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AESCULAP AG KAIRISON PNEUM.PUNCH HANDLE BONE PUNCHES, RONGEURS Back to Search Results
Model Number FK899R
Device Problem Explosion (4006)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/03/2019
Event Type  malfunction  
Manufacturer Narrative
Manufacturing site evaluation: investigation on-going. Additional information / investigation results will be provided in a supplemental report, if received.
 
Event Description
It was reported that there was an issue with a kairison pneum. Punch handle. It was reported that when the surgeon pulled the trigger, the hand piece "exploded". A second set/tray was pulled to be utilized in surgery. The type of surgery was a laminectomy. There was no patient harm. An additional medical intervention was not necessary. This malfunction prolonged the surgery for 30 minutes. Additional information has been requested but not yet received as of this report. The malfunction is filed under aag reference (b)(4).
 
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Brand NameKAIRISON PNEUM.PUNCH HANDLE
Type of DeviceBONE PUNCHES, RONGEURS
Manufacturer (Section D)
AESCULAP AG
po box 40
tuttlingen, 78501
GM 78501
Manufacturer (Section G)
AESCULAP AG
po box 40
tuttlingen, 78501
GM 78501
Manufacturer Contact
nadine schweikart
po box 40
tuttlingen, 78501
GM   78501
MDR Report Key9758276
MDR Text Key184321432
Report Number9610612-2019-00997
Device Sequence Number1
Product Code HAD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K062413
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/18/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/26/2020
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFK899R
Device Catalogue NumberFK899R
Device Lot Number52007192
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/24/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/23/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/19/2014
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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