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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY ROBI METZENBAUM SCISSORS INSERT
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KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY ROBI METZENBAUM SCISSORS INSERT Back to Search Results
Model Number 38610MW
Medical Device Problem Code Material Separation (1562)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 06/30/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The instrument was returned and evaluated.It was found that a piece of metal that covers the inner side of the scissors jaw had come off.A possible cause was stress overload.
 
Event or Problem Description
Allegedly, the doctor was performing a procedure when he noted that a piece came off one of the jaws into the patient.He immediately retrieved piece, replaced instrument and completed procedure.The hospital reported there was no injury to the patient.
 
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Brand Name
ROBI METZENBAUM SCISSORS INSERT
Common Device Name
SCISSORS INSERT
Manufacturer (Section D)
KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY
mittlestrasse 8,
78503
tuttlingen
MDR Report Key6789971
Report Number9610617-2017-00065
Device Sequence Number132527
Product Code GEI
UDI-Device Identifier04048551328750
UDI-Public4048551328750
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K962030
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Attorney
Type of Report Initial
Report Date (Section B) 07/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Physician
Device Model Number38610MW
Device Catalogue Number38610MW
Device Lot NumberPT
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/24/2017
Was the Report Sent to FDA? No
Event Location Hospital
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/13/2017
Initial Report FDA Received Date08/11/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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