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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ ENDOSCOPY-AMERICA, INC. STORZ BOWEL GRASPER INSERT LAPAROSCOPE, GENERAL & PLASTIC SURGERY

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KARL STORZ ENDOSCOPY-AMERICA, INC. STORZ BOWEL GRASPER INSERT LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Model Number 334LOC
Device Problems Break (1069); Detachment of Device or Device Component (2907); Tip (3123)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/09/2020
Event Type  Malfunction  
Event Description

One section of the bowel grasper tip broke off inside the pt. Tip was removed and x-ray was completed to ensure grasper tip was successfully removed. Fda safety report id# (b)(4).

 
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Brand NameSTORZ BOWEL GRASPER INSERT
Type of DeviceLAPAROSCOPE, GENERAL & PLASTIC SURGERY
Manufacturer (Section D)
KARL STORZ ENDOSCOPY-AMERICA, INC.
MDR Report Key9882873
MDR Text Key185223404
Report NumberMW5093927
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
Type of Report Initial
Report Date 03/24/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/25/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number334LOC
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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