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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG SAGITTAL SAW ATTACHMENT F/GA344/GA844 POWER SYSTEMS

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AESCULAP AG SAGITTAL SAW ATTACHMENT F/GA344/GA844 POWER SYSTEMS Back to Search Results
Model Number GB891R
Device Problem Use of Device Problem (1670)
Patient Problem No Code Available (3191)
Event Date 08/03/2020
Event Type  Injury  
Manufacturer Narrative

Investigation on going. Additional information / results will be submitted in a supplemental report.

 
Event Description

It was reported that there was an issue with sagittal saw. It was reported that the holding clamb springs apart during sawing. The malfunction occurred during a foot operation on 08. 03. 2020. The operation was delayed by about 10 minutes to get and open another screen. There was no patient harm. This event/malfunction prolonged the surgery for 10 minutes. Additional information has been requested but not yet received as of this report. Additional patient information is not available. The adverse event / malfunction is filed under aag reference (b)(4).

 
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Brand NameSAGITTAL SAW ATTACHMENT F/GA344/GA844
Type of DevicePOWER SYSTEMS
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
christian von der grün
po box 40
tuttlingen, 78501
GM   78501
MDR Report Key10546978
MDR Text Key207343334
Report Number9610612-2020-00514
Device Sequence Number1
Product Code HAB
Combination Product (Y/N)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 10/27/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/17/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberGB891R
Device Catalogue NumberGB891R
Device LOT Number52393645
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/26/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/28/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/26/2018
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 09/17/2020 Patient Sequence Number: 1
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