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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG DEEP CUTT.SAW F/GB124R 45/20/0.6/ POWER SYSTEMS ORTHOPAEDICS

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AESCULAP AG DEEP CUTT.SAW F/GB124R 45/20/0.6/ POWER SYSTEMS ORTHOPAEDICS Back to Search Results
Model Number GC502R
Device Problem Unclear Information (4052)
Patient Problem Laceration(s) (1946)
Event Date 09/17/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Reported device not marketed in the u. S. , however, similar devices or devices that share components, raw materials, process methods or other technological characteristics are registered within the u. S. Manufacturing site evaluation: the device was not returned to the manufacturer. An evaluation of the complaint will be performed based on information obtained in the complaint. Pending further information. If additional information becomes available a supplemental report will be submitted.

 
Event Description

It was reported by the user facility to the company sales representative, "the sternum saw blades now come unassembled. The manufacturer only supplied a picture of how the pieces go together. There were no instructions or orientation of blade on the shaft or how tight the nut should be installed. As a facility service technician was installing the blade onto the shaft, one of the two aesculap wrench's slipped off the nut and cut the technicians finger. The facility had already brought this forward as a health and safety issue, if the facility staff were to assemble these on site. " there was no specific information provided regarding the extent of the injury other than it was a minor cut. The product was not being used on a patient at the time of the incident. There was no delay in critical therapy when problem was noted. The device and components will not be sent back to aesculap. Updated information received on 15oct2018: there was no medical attention required for the technician.

 
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Brand NameDEEP CUTT.SAW F/GB124R 45/20/0.6/
Type of DevicePOWER SYSTEMS ORTHOPAEDICS
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 Key7994766
MDR Text Key125612532
Report Number9610612-2018-00464
Device Sequence Number1
Product Code HAB
Combination Product (Y/N)N
Reporter Country CodeCA
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,USER FACILITY
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/28/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/23/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator OTHER
Device MODEL NumberGC502R
Device Catalogue NumberGC502R
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Distributor Facility Aware Date10/31/2018
Event Location No Information
Date Manufacturer Received10/31/2018
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 Unkown

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