Catalog Number AS11912-17 |
Device Problem
Dull, Blunt (2407)
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Patient Problem
Tissue Damage (2104)
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Event Type
malfunction
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Manufacturer Narrative
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A product sample was received and it is awaiting 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.(b)(4).
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Event Description
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A nurse reported that the substitute blades are not as sharp, have burs and are wider which reportedly resulted in jagged incisions.The facility reports exchanging the blade to complete the procedures.Additional information and product sample have been requested.
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Manufacturer Narrative
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This is the first complaint reported for this finished goods lot.Review of the device history record indicates the order was built to specification.One unopened blade was returned for this complaint.Visual inspection of the knife in the lab was unable to confirm the customer's complaint of a dull blade.The sample was sent to the supplier so that a thorough investigation of the blade could be performed.Though the definitive root cause could not be determined in the lab, the most likely root cause of the customer's complaint of unacceptable, dull blades is an error that occurred during the supplier's manufacturing process.The root cause of the customer¿s dissatisfaction with the knife substitution is due to a temporary deviation which occurred due to a backorder with the supplier.During the backorder, a substitute knife was approved for use.Quality engineering materials has notified the supplier and sent the sample for further investigation.Quality assurance will continue to monitor and take action for any future occurrences as is deemed necessary.(b)(4).
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Search Alerts/Recalls
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