MAUDE Adverse Event Report: CAREFUSION, INC T-COAT MICRO HDL KERR RONG THIN 8IN 4MM; KERRISON RONGEURS

Catalog Number NL4258-84T

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/27/2020

Event Type  malfunction  

Manufacturer Narrative

Pr # (b)(4).On (b)(6) 2020 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 email: tip of instrument was broken during procedure.Was product used on patient? yes.Did the failure occur during patient use? yes.Was there any patient harm? no.Medical intervention required? no.Was there any user harm? no.No further information available.

Event Description

Per email: tip of instrument was broken during procedure.Was product used on patient? yes.Did the failure occur during patient use? yes.Was there any patient harm? no.Medical intervention required? no.Was there any user harm? no.No further information available.

Manufacturer Narrative

The product was returned, and an evaluation was performed.The root cause of the reported issue is that the instrument has been reworked by an unauthorized 3rd party repair.Hardness is 46.6 hrc (inside the tolerance 43-48 hrc).A review of the material batch found no irregularities.The device was subjected to a microscopic examination.Marks on the slider and on the screw indicate improper repair by an unauthorized repair company.It appears that the foot plate was grinded by the repair site, reducing material stability and thus increasing the risk of breakage.The foot plate cannot be checked because this piece is missing.The customer confirmed that the tip was removed from the patient.There have been no issues identified with the material or manufacturing process.The product has been manufactured and tested according to the specifications.A review of the device history records (dhr) did not identify and issues that would have contributed to the reported issue.

• Brand Name: T-COAT MICRO HDL KERR RONG THIN 8IN 4MM
• Type of Device: KERRISON RONGEURS
• Manufacturer (Section D): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• MDR Report Key: 10549446
• MDR Text Key: 221544081
• Report Number: 1423507-2020-00038
• 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: other,user facility
• Type of Report: Initial,Followup
• Report Date: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NL4258-84T
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 08/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other