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U.S. Department of Health and Human Services

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

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CAREFUSION, INC LOVE-GRUENWALD PITUITARY FORCEPS 2X10MM KERRISON RONGEURS Back to Search Results
Catalog Number NL6146
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/18/2019
Event Type  malfunction  
Manufacturer Narrative
Pr # (b)(4). The sample was provided, and an evaluation was performed. The root cause of the issue is undetermined. On the right side of the upper shaft at the end, a small section is missing. The rivet is welded clean on both sides. The breaking point shows no reflection. It is incomprehensible why the section is missing. There have been no issues identified with the material or manufacturing process. The product has been manufactured and tested according to the specifications.
 
Event Description
Via email: pituitary broke during routine usage. 24jun2019 additional information: what was the procedure that was being performed? tlif. Did any part the instrument fall into the patient¿s body, and if so how was it retrieved? no. Was there a medical procedure performed to verify if the instrument was in the patient¿s body, such as an x-ray? yes, an x-ray was taken in operating room. What was the patient¿s outcome? as expected. Pt was stable upon discharge. Was the procedure completed as planned? yes. Can you please send all parts of the instrument for evaluation? yes. Do you have the lot number? i believe it¿s 0905. I am not entirely sure if that¿s the lot or a misc number. 03jul2019 additional information: x-ray is used throughout the case that the instrument was being used for. The surgeon was using the instrument to perform his scheduled procedure. The instrument stopped working and was removed from the sterile field. I have provided all of the information that was provided to me from the surgeon. This happened during a case. I was not scrubbed into the case. Therefore, i am unable to give you the specific details that i believe you¿re looking for. It was handed to the cst and the surgeon stated that the instrument was not working. Once it was inspected by our spd tech and me it was very clear that the instrument was broken and not working as it is intended to work. 08jul2019 additional information: so it is more of it not functioning as intended and not a screw falling out as far as you know? yes, as far as i know. 10jul2019 additional information: after inspecting the instrument, there is definitely a screw that is missing. Our question is, was the doctor using this instrument, and then it stopped functioning (a screw popped out)? or, was the instrument handed to the doctor already in a broken state, with the screw missing, and then not even used on the patient? i do not know the answer to that question. I was not in the room and the surgeon did not inform me of any screws popping out during the procedure. He simply stated that the instrument was ¿not working¿. I hope that helps. No further information available.
 
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Brand NameLOVE-GRUENWALD PITUITARY FORCEPS 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 Key8811440
MDR Text Key209398409
Report Number1423507-2019-00011
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 consumer,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/22/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNL6146
Device Lot NumberJ17XSX
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/18/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2017
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 07/22/2019 Patient Sequence Number: 1
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