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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG KAIRISON PNEUM.PUNCH PRESSURE REDUCER RONGEUR, POWERED

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AESCULAP AG KAIRISON PNEUM.PUNCH PRESSURE REDUCER RONGEUR, POWERED Back to Search Results
Model Number FK898R
Device Problem Use of Device Problem (1670)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/06/2018
Event Type  malfunction  
Manufacturer Narrative
Investigation: the investigation was carried out visually and a functional test was performed. The connectin pins are no longer according to the specifications, since they are deformed, most likely caused by a drop. Due to these damages, a proper mounting of the disposable tube set fk888su can no longer be guaranteed. The functional test was carried out successfully, but the set could only be assembled with high forces. Without a correct connection of the tube set, the function of the kairison bone punch will not be according to specification. Conclusion and root cause: based on the information available as well as a result of our investigation, the root cause of the failure is most probably related to an insufficient usage. No capa is necessary.
 
Event Description
Country of complaint: (b)(6). Io would not engage shaft.
 
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Brand NameKAIRISON PNEUM.PUNCH PRESSURE REDUCER
Type of DeviceRONGEUR, POWERED
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
nicole broyles
615 lambert pointe drive
hazelwood, MO 63042
MDR Report Key7790280
MDR Text Key117438995
Report Number9610612-2018-00311
Device Sequence Number1
Product Code HAD
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K062413
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 08/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/16/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFK898R
Device Catalogue NumberFK898R
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/24/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Distributor Facility Aware Date07/16/2018
Event Location No Information
Date Manufacturer Received07/16/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2017
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: 08/16/2018 Patient Sequence Number: 1
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