Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ SE & CO. KG OPTICAL BIOPSY FORCEPS; OPTICAL GRASPING FORCEPS
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

KARL STORZ SE & CO. KG OPTICAL BIOPSY FORCEPS; OPTICAL GRASPING FORCEPS Back to Search Results
Model Number 27072A
Medical Device Problem Code Connection Problem (2900)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 10/27/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The instrument has a broken drawbar linkage and indentation on the jaw.The instrument is over 2 years old and shows sign of long usages.
 
Event or Problem Description
Allegedly, per the customer during a urology procedure a screw or rivet on the jaw broke off in the patients bladder.The piece was retrieved, the procedure was completed with no further intervention required or harm to the patient.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
OPTICAL BIOPSY FORCEPS
Common Device Name
OPTICAL GRASPING FORCEPS
Manufacturer (Section D)
KARL STORZ SE & CO. KG
dr.-karl-storz-strasse 34
78532
tuttlingen, gm
MDR Report Key10891272
Report Number9610617-2020-00132
Device Sequence Number11470363
Product Code OCZ
UDI-Device Identifier04048551079157
UDI-Public4048551079157
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
PMA/510(K) Number
K950434
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 11/23/2020
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? No
Operator of Device Health Professional
Device Model Number27072A
Device Catalogue Number27072A
Device Lot NumberVR
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/09/2020
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/27/2020
Initial Report FDA Received Date11/24/2020
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 Required Intervention;
-
-