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

Catalog Number NL6146

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/09/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4) on (b)(6) 2019, 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

It was reported via email: yesterday one of our pituitary¿s had a piece of metal come off during a case.The tech saw it and it wasn¿t left in the patient, but we had to take it out of service.What was the procedure that was being performed? cervical disc replacement.Did any part the instrument fall into the patient¿s body, and if so, how was it retrieved? unknown.Was there a medical procedure performed to verify if the instrument was in the patient¿s body, such as an x-ray? x-ray down, nothing seen on x-ray.What was the patient¿s outcome? stable, normal outcome.Was the procedure completed as planned? yes.Can you please send all parts of the instrument for evaluation? yes, metal piece was found and matched to instrument.Do you have the lot number? j17xsx.Could you please clarify where was the broken piece found? it was found on a sponge by the scrub tech after wiping the instrument after normal use.No further information available.

Event Description

It was reported via email: yesterday one of our pituitary¿s had a piece of metal come off of it during a case.The tech saw it and it wasn¿t left in the patient, but we have to obviously take it out of service and we need a new one.What was the procedure that was being performed? cervical disc replacement.Did any part the instrument fall into the patient¿s body, and if so how was it retrieved? unknown.Was there a medical procedure performed to verify if the instrument was in the patient¿s body, such as an x-ray? xray down, nothing seen on xray.What was the patient¿s outcome? stable, normal outcome.Was the procedure completed as planned? yes.Can you please send all parts of the instrument for evaluation? yes, metal piece was found and matched to instrument.Do you have the lot number? j17xsx.Could you please clarify where was the broken piece found? it was found on a sponge by the scrub tech after wiping the instrument after normal use.

Manufacturer Narrative

Follow up (b)(6): the sample was provided, and an evaluation was performed.The root cause of the reported issue is due to improper use.The function of the mouth works, and the pin from the upper shaft is firmly welded.The material hardness meets the specification range of 44-48 hrc.The deviation is due to user error or a poorly performed repair.It is noticeable that a slight notch becomes visible below the missing spot.In addition, a different degree of matting is visible in the front area of the shaft.There have been no issues identified with the material or manufacturing process.The product has been manufactured and tested according to the specifications.

• 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
• MDR Report Key: 8262616
• MDR Text Key: 135508655
• Report Number: 1423507-2019-00001
• Device Sequence Number: 1
• Product Code: HAE
• Combination Product (y/n): N
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 03/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 01/10/2019
• Initial Date FDA Received: 01/18/2019
• Supplement Dates Manufacturer Received: 01/10/2019
• Supplement Dates FDA Received: 03/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other