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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ ENDOSCOPY-AMERICA, INC. OPTICAL FORCEPS, FOR BIOPSY; ENDOSCOPIC FIRCEPS, BIOPSY, RIGID
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KARL STORZ ENDOSCOPY-AMERICA, INC. OPTICAL FORCEPS, FOR BIOPSY; ENDOSCOPIC FIRCEPS, BIOPSY, RIGID Back to Search Results
Catalog Number 27072A
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 03/31/2023
Type of Reportable Event Malfunction
Event or Problem Description
The event occurred in great britain.It was reported that the instrument failed during use.A rivet fell out.The rivet was retrieved during the procedure.
 
Additional Manufacturer Narrative
The event is filed under internal karl storz complaint id: (b)(4).Pending further results a supplemental report will be filed.
 
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Brand Name
OPTICAL FORCEPS, FOR BIOPSY
Common Device Name
ENDOSCOPIC FIRCEPS, BIOPSY, RIGID
Manufacturer (Section D)
KARL STORZ ENDOSCOPY-AMERICA, INC.
2151 e grand ave
el segundo CA 90245
MDR Report Key16761420
Report Number2020550-2023-00081
Device Sequence Number19563255
Product Code OCZ
UDI-Device Identifier04048551079157
UDI-Public4048551079157
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
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) 04/17/2023
Report Date (Section F) 04/17/2023
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 Health Professional
Device Catalogue Number27072A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date04/17/2023
Event Location Hospital
Date Report to Manufacturer04/17/2023
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date04/18/2023
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient SexUnknown
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