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

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.

• Brand Name: LOVE-GRUENWALD PITUITARY FORCEPS 2X10MM
• Type of Device: KERRISON 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 Key: 8811440
• MDR Text Key: 209398409
• Report Number: 1423507-2019-00011
• Device Sequence Number: 1
• Product Code: HAE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• 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 Received: 07/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NL6146
• Device Lot Number: J17XSX
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other