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

Model Number BB524

Device Problems Nonstandard Device (1420); Delivered as Unsterile Product (1421)

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

Event Date 08/18/2021

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 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).

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
• Type of Device: 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
• MDR Text Key: 281165436
• Report Number: 9610612-2021-00688
• Device Sequence Number: 1
• Product Code: GES
• UDI-Device Identifier: 04038653338504
• UDI-Public: 4038653338504
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 11/25/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1