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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GEOMED MEDIZIN-TECHNIK GMBH & CO. KG GOLD-CUT METZ SCISSORS FINE 18 CM SURGICAL SCISSORS

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GEOMED MEDIZIN-TECHNIK GMBH & CO. KG GOLD-CUT METZ SCISSORS FINE 18 CM SURGICAL SCISSORS Back to Search Results
Catalog Number AD 561-18-01 / 101261
Device Problem Fracture (1260)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The device history record, including acceptance testing results, was reviewed and found to conform to specifications. The device was subject to microscopic inspection and no signs of excessive force or pressure were found. Due to all of the above, in addition to the fact that the device was returned incomplete, i. E. , the broken-off tip is not available for inspection, it has not been possible to establish the cause of failure.
 
Event Description
According to the dealer, the instrument tip was broken during orthopedic surgery. No broken parts inside the patient. No harm done.
 
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Brand NameGOLD-CUT METZ SCISSORS FINE 18 CM
Type of DeviceSURGICAL SCISSORS
Manufacturer (Section D)
GEOMED MEDIZIN-TECHNIK GMBH & CO. KG
ludwigstaler strasse 27
tuttlingen, baden-wuerttemberg 78532
GM 78532
Manufacturer (Section G)
GEOMED MEDIZIN-TECHNIK GMBH & CO. KG
ludwigstaler strasse 27
tuttlingen, baden-wuerttemberg 78532
GM 78532
Manufacturer Contact
hanno haug
ludwigstaler strasse 27
tuttlingen, baden wuerttemberg 78532
GM   78532
746193550
MDR Report Key6197784
MDR Text Key63489591
Report Number8010168-2016-00003
Device Sequence Number1
Product Code HRR
Combination Product (y/n)N
Reporter Country CodeEG
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 12/22/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/22/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberAD 561-18-01 / 101261
Device Lot Number136
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/24/2016
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/22/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/08/2013
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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