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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ ENDOSCOPY - AMERICA, INC. KARL STORZ; BOWEL GRASPER / LAPAROSCOPIC GENERAL AND PLASTIC

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KARL STORZ ENDOSCOPY - AMERICA, INC. KARL STORZ; BOWEL GRASPER / LAPAROSCOPIC GENERAL AND PLASTIC Back to Search Results
Catalog Number 33310C
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/01/2018
Event Type  malfunction  
Event Description
During the procedure, the laparoscopic instrument (karl storz bowel grasper) was being used inside the pt when it was noticed that half of the jaw had broken in half.It was immediately removed from the pt's cavity in its entirety.The broken piece was removed intact and the cavity was assessed by the attending physician and it was confirmed that no pieces were left behind.
 
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Brand Name
KARL STORZ
Type of Device
BOWEL GRASPER / LAPAROSCOPIC GENERAL AND PLASTIC
Manufacturer (Section D)
KARL STORZ ENDOSCOPY - AMERICA, INC.
MDR Report Key7772144
MDR Text Key116911837
Report NumberMW5079029
Device Sequence Number1
Product Code GCJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/08/2018
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
Device Operator No Information
Device Catalogue Number33310C
Device Lot NumberOX09
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/09/2018
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age73 YR
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