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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ SE & CO. KG OPTICAL BIOPSY FORCEPS; OPTICAL GRASPING FORCEPS
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KARL STORZ SE & CO. KG OPTICAL BIOPSY FORCEPS; OPTICAL GRASPING FORCEPS Back to Search Results
Model Number 27072A
Device Problem Material Twisted/Bent (2981)
Patient Problems No Consequences Or Impact To Patient (2199); Unspecified Kidney or Urinary Problem (4503)
Event Date 08/04/2020
Event Type  malfunction  
Manufacturer Narrative
Product has not been returned and therefore, could not be evaluated.
 
Event Description
Allegedly, per the customer during a bladder stone procedure the forceps cup bent and would not open.Per the customer "we broke cup to remove from sheath", nothing fell inside the patient and procedure was completed with no further intervention required or harm to the patient.
 
Manufacturer Narrative
The evaluation of the returned instrument date code nr08(01/2018) distal end of shaft is crushed and tip and jaws are missing.
 
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Brand Name
OPTICAL BIOPSY FORCEPS
Type of Device
OPTICAL GRASPING FORCEPS
Manufacturer (Section D)
KARL STORZ SE & CO. KG
dr.-karl-storz-strasse 34
78532
tuttlingen, gm,
MDR Report Key10487715
MDR Text Key205487538
Report Number9610617-2020-00098
Device Sequence Number1
Product Code OCZ
UDI-Device Identifier04048551079157
UDI-Public4048551079157
Combination Product (y/n)N
PMA/PMN Number
K950434
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 09/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number27072A
Device Catalogue Number27072A
Device Lot NumberNR
Was Device Available for Evaluation? Yes
Date Manufacturer Received08/06/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age76 YR
Patient Weight84
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