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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG AESCULAP SURGICAL INSTRUMENTS GENERAL SURGICAL INSTRUMENTS

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AESCULAP AG AESCULAP SURGICAL INSTRUMENTS GENERAL SURGICAL INSTRUMENTS Back to Search Results
Model Number AESCULAP010
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/08/2017
Event Type  malfunction  
Manufacturer Narrative
Investigation: no product is at hand. Conclusion and root cause: based on the information available, the root cause of the failure is most probably related to an insufficient usage or maintenance of the device. Rational: based on the quality standards we exclude a material or manufacturer caused error. No capa is necessary.
 
Manufacturer Narrative
(b)(4). Manufacturing site evaluation: evaluation on-going. Device not returned.
 
Event Description
Country of complaint: usa. Neurosurgeon was using the number three kerrison instrument during a surgical procedure, a screw came loose on the kerrison and fell into the spinal cord. Neurosurgeon had to dig around in the opening with the suction and cst used a forcep to quickly grab it before it went into the neptune. No harm was done to the patient and instrument was reported.
 
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Brand NameAESCULAP SURGICAL INSTRUMENTS
Type of DeviceGENERAL SURGICAL INSTRUMENTS
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
3145515988
MDR Report Key7219320
MDR Text Key272302726
Report Number2916714-2018-00003
Device Sequence Number1
Product Code HAE
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 01/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/25/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAESCULAP010
Device Catalogue NumberAESCULAP010
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Distributor Facility Aware Date01/22/2018
Event Location No Information
Date Manufacturer Received01/04/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/25/2018 Patient Sequence Number: 1
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