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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ROBI KELLY FORCEPS INSERT; RIGID FORCEPS
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KARL STORZ SE & CO. KG ROBI KELLY FORCEPS INSERT; RIGID FORCEPS Back to Search Results
Model Number 38610MD
Medical Device Problem Code Application Program Problem: Dose Calculation Error (1189)
Health Effect - Clinical Code Tachycardia (2095)
Date of Event 06/27/2024
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that the use of a robi clamp caused tachycardia in a patient.The surgeon suspects that these arrhythmias are due to a loss of seal in the clamp, which may be allowing current to pass through.
 
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
 
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Brand Name
ROBI KELLY FORCEPS INSERT
Common Device Name
RIGID FORCEPS
Manufacturer (Section D)
KARL STORZ SE & CO. KG
dr.-karl-storz-strasse 34
tuttlingen, 78532
GM  78532
MDR Report Key19691863
Report Number2020550-2024-00203
Device Sequence Number8376047
Product Code GEI
UDI-Device Identifier04048551328682
UDI-Public4048551328682
Combination Product (Y/N)N
Initial Reporter CountryFR
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Importer
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 07/08/2024
Report Date (Section F) 07/08/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number38610MD
Device Catalogue Number38610MD
Device Lot NumberPL47
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date07/03/2024
Event Location Hospital
Date Report to Manufacturer07/08/2024
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date07/08/2024
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient SexUnknown
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