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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION, INC LOVE-GRUENWALD PITUITARY FORCEP 2X10MM KERRISON RONGEURS

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CAREFUSION, INC LOVE-GRUENWALD PITUITARY FORCEP 2X10MM KERRISON RONGEURS Back to Search Results
Model Number NL6147
Device Problems Break (1069); No Apparent Adverse Event (3189)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/15/2021
Event Type  malfunction  
Manufacturer Narrative
Mw5099486 - pr # (b)(4), 02apr2021 writer sent the customer an email acknowledging receipt of the complaint, providing the complaint tracking number and requested follow up information including as to if there was any patient impact related to this event. Writer provided contact information. Device not yet evaluated, if the device is evaluated a follow up will be sent.
 
Event Description
Per attached complaint details from mw5099486: dr was using clamp to remove the head of the femur due during the surgical case. The jaws broke and was retrieved using c-arm fda safety report id# (b)(4). It was reported that instrument broke during surgery and retrieved via c-arm. 07apr2021 customer response: what is the lot number? i do not see a lot number on this instrument. Please confirm whether or not there was any patient injury. There was no harm to the patient that i am aware of. No further information available.
 
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Brand NameLOVE-GRUENWALD PITUITARY FORCEP 2X10MM
Type of DeviceKERRISON RONGEURS
Manufacturer (Section D)
CAREFUSION, INC
75 north fairway drive
vernon hills IL 60061
Manufacturer (Section G)
CAREFUSION, INC
75 north fairway drive
vernon hills IL 60061
Manufacturer Contact
anna wehrheim
75 north fairway drive
vernon hills, IL 60061
8015652341
MDR Report Key11675248
MDR Text Key249688482
Report Number1423507-2021-00026
Device Sequence Number1
Product Code HAE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PREAMENDMENT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/25/2021,06/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNL6147
Device Catalogue NumberNL6147
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/25/2021
Device Age13 YR
Event Location Hospital
Date Report to Manufacturer04/15/2021
Date Manufacturer Received04/01/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 04/15/2021 Patient Sequence Number: 1
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