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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GEOMED MEDIZIN-TECHNIK GMBH & CO. KG GOLD-CUT IRIS SCISSORS SP/SP GER 11.5CM SURGICAL SCISSORS

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GEOMED MEDIZIN-TECHNIK GMBH & CO. KG GOLD-CUT IRIS SCISSORS SP/SP GER 11.5CM SURGICAL SCISSORS Back to Search Results
Catalog Number AD 784-11-01 / 101300
Device Problems Fracture (1260); Off-Label Use (1494)
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 showed no signs of pre-existing material damage due to stress corrosion cracking, which indicates that the device may have been subject to inappropriate use. It must also be considered that the scissors involved in the event are delicate scissors intended for ophthalmic use, not for ent surgery. However, due 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 conclusively establish the cause of failure.
 
Event Description
According to the dealer, the instrument tip was broken during ent surgery. No broken parts inside the patient. No harm done.
 
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Brand NameGOLD-CUT IRIS SCISSORS SP/SP GER 11.5CM
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 Key6197783
MDR Text Key63489691
Report Number8010168-2016-00004
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 784-11-01 / 101300
Device Lot Number248
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 Manufactured08/20/2013
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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