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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG KAIRISON PNEUM.PUNCH HANDLE PNEUMATIC INSTRUMENTS

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AESCULAP AG KAIRISON PNEUM.PUNCH HANDLE PNEUMATIC INSTRUMENTS Back to Search Results
Model Number FK899R
Device Problem Air Leak (1008)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/01/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Manufacturing site evaluation: evaluation on-going.
 
Event Description
Country of complaint: (b)(6). It is reported that the air releasing out the bottom of the handle. No patient injury. Delay in surgery was 20 minutes.
 
Manufacturer Narrative
Investigation: the investigation was carried out by the responsible q-coordinator of the production plant. Several scratches and friction marks can be found on the connection pin. A functional test was successfully performed, but an air leakage at the handle could not be confirmed. Most likely the disposable air hose fk888su has not been mounted correctly to the handle and thus a leakage occurred. Batch history review: the device quality and manufacturing records have been checked for the available lot number. The device history file has been checked and found to be according to our specification valid at the time of production. No similar incidents have been filed with products from this batch. 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.
 
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Brand NameKAIRISON PNEUM.PUNCH HANDLE
Type of DevicePNEUMATIC INSTRUMENTS
Manufacturer (Section D)
AESCULAP AG
po box 40
tuttlingen, 78501
GM 78501
MDR Report Key7652660
MDR Text Key112999724
Report Number9610612-2018-00282
Device Sequence Number1
Product Code HAD
Combination Product (y/n)N
PMA/PMN Number
K062413
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 08/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/29/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFK899R
Device Catalogue NumberFK899R
Device Lot Number52308290
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/27/2018
Was the Report Sent to FDA?
Distributor Facility Aware Date06/19/2018
Device Age15 MO
Event Location No Information
Date Manufacturer Received06/01/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 06/29/2018 Patient Sequence Number: 1
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