MAUDE Adverse Event Report: AESCULAP AG CARBON STEEL SCALPEL BLADES #12D; BASIC INSTRUMENTS

Model Number BB542

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with a carbon steel scalpel blade.According to the complaint description the blade broke in mouth of the patient during surgery.The customer claims that there is a high risk of loosing the broken piece in patients mouth.There was no patient harm.Additional information was not provided nor available.The malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation results: visual investigation: vigilance investigator carried out the pictorial documentation visually and microscopically.The scalpel blades sent as opened and "used" samples for demonstration to the sales representative.Furthermore unopened blades have been sent back.During a test with unopened samples the deformation and breakage of the tip could be reproduced by tipping the tip with force to a hard surface.The microscopic investigation showed a deviation of the tip shape from the shape in the drawing.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.Review of the complaint history revealed that there is one similar complaint filed against products from this batch number.The review of risk assessment revealed that the overall risk level (severity x probability of occurrence) according to din en iso 14971 is still acceptable.Conclusion and measures / preventive measures: the form of the scalpel blades tip is not according to the specification and the tip is very flexible.This is caused by a manufacturing issue and will be investigated by the manufacturing plant.Based upon the investigations results there is capa is not necessary.An analysis and corrective action has been requested to the production plant.

• Brand Name: CARBON STEEL SCALPEL BLADES #12D
• Type of Device: BASIC INSTRUMENTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10620119
• MDR Text Key: 209589673
• Report Number: 9610612-2020-00623
• Device Sequence Number: 1
• Product Code: GES
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/09/2021

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 Model Number: BB542
• Device Catalogue Number: BB542
• Device Lot Number: 4511331965
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2020
• Initial Date Manufacturer Received: 09/10/2020
• Initial Date FDA Received: 10/02/2020
• Supplement Dates Manufacturer Received: 01/22/2021
• Supplement Dates FDA Received: 02/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1