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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIRAJ INDUSTRIES PVT. LTD. TECHNO-CUT SURGICAL BLADE BLADE, SCALPEL

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NIRAJ INDUSTRIES PVT. LTD. TECHNO-CUT SURGICAL BLADE BLADE, SCALPEL Back to Search Results
Model Number 0473
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/21/2021
Event Type  malfunction  
Event Description
Blade broke in half during a robotic spine procedure. Fortunately the piece was recovered and there was no harm to the pt. Fda safety report id# (b)(4).
 
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Brand NameTECHNO-CUT SURGICAL BLADE
Type of DeviceBLADE, SCALPEL
Manufacturer (Section D)
NIRAJ INDUSTRIES PVT. LTD.
MDR Report Key13118109
MDR Text Key283140052
Report NumberMW5106362
Device Sequence Number1
Product Code GES
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 12/27/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0473
Device Lot Number1729 10AC
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Is This a Reprocessed and Reused Single-Use Device? No

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