Catalog Number 9215320001 |
Device Problem
Bent (1059)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Type
malfunction
|
Manufacturer Narrative
|
No sample has been received by manufacturing for evaluation.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.This is the second of two reports from this facility.(b)(4).
|
|
Event Description
|
A nurse reported that multiple knife blades were bent or barbed.Procedure details, patient involvement and patient impact information is unknown.
|
|
Manufacturer Narrative
|
Additional information is provided.The manufacturer internal reference number is: (b)(4).
|
|
Event Description
|
Additional information received clarified that the unsatisfactory knives were noted prior to surgery during set up when the knives were viewed under the microscope.There was no patient contact therefore, no impact to any patient.
|
|
Manufacturer Narrative
|
No sample has been returned for evaluation for the report of blades were bent or barbed therefore, the condition of the product could not be verified.A review of the device history record related to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.A complaint history examination indicates that there is one additional complaint associated with the lot for the reported issue.A sample was not returned and the device history record review of the lot number provided indicates that the product was processed and released according to acceptance criteria therefore, the root cause for the customer complaint issue cannot be determined.The exact root cause for this complaint is unknown therefore, specific action with regards to this complaint cannot be taken.All knives are 100% inspected by trained operators using a minimum of 10x magnification during manufacturing.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No additional action is required at this time.The manufacturer internal reference number is: (b)(4).
|
|
Search Alerts/Recalls
|