MAUDE Adverse Event Report: AESCULAP AG CARBON STEEL SCALPEL BLADES #24; GENERAL SURGICAL INSTRUMENTS

Model Number	BB524
Medical Device Problem Codes	Nonstandard Device (1420); Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
Event or Problem Description
It was reported that there was an issue with bb524 - carbon steel scalpel blades #24.According to the complaint description, the carbon steel scalpel blades are non sterile.There was no described patient harm.Additional information was not provided.Additional patient information is not available.The malfunction is filed under (b)(4).
Additional Manufacturer Narrative
Based upon investigation results, this event was re-evaluated and is considered no longer reportable due to risk file- no malfunction or serious injury.Investigation results: visual investigation: the investigation was carried out visually and microscopically with the digital microscope and the digital-camera.We carried out a visual inspection of all the products.Every packaging was penetrated by the scalpel blades.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 no similar complaints have been filed against products from this batch number.The review of risk assessment revealed that the overall risk level (severity 2 (5) probability of occurrence 1(5)) according to din en iso (b)(4) is still acceptable.Conclusion and measures / preventive measures: according to the quality standard and the dhr files, a material defect and a production defect can be excluded.Investigations lead to the assumption that the visible damages were caused by improper transport of the goods.Based upon the investigations results a capa is not necessary.

• Brand Name: CARBON STEEL SCALPEL BLADES #24
• Common Device Name: GENERAL SURGICAL INSTRUMENTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 12618020
• Report Number: 9610612-2021-00688
• Device Sequence Number: 1348966
• Product Code: GES
• UDI-Device Identifier: 04038653338504
• UDI-Public: 4038653338504
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/10/2026
• Device Model Number: BB524
• Device Catalogue Number: BB524
• Device Lot Number: 4512260156
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2021
• Supplement Date Received by Manufacturer: 11/25/2021
• Initial Report FDA Received Date: 10/12/2021
• Supplement Report FDA Received Date: 12/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown