MAUDE Adverse Event Report: AESCULAP AG CARBON STEEL SCALPEL BLADES #15

Model Number BB515

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: the blade is broken about 1/3 of the length from the distal end.The analysis of the fracture pattern illustrated a forced fracture due to overload.No pores, inclusions or foreign bodies could be found on the point of rupture.The edge is damaged, most likely caused by an overload situation, e.G.Too much pressure during cutting.Additionally, the damaged proximal end is also an indicator for an overload situation, e.G.Leverage during application.The device quality and manufacturing history records have been checked for all available lot numbers and found to be according to our specifications valid at the time of production.No similar incidents have been filed with products from this batch.Based on the information available as well as a result of our investigation the root cause of the failure is most probably related to an insufficient usage.The breakage of the blade was most likely caused by an overload situation, e.G.Leverage and/or too much pressure during cutting, e.G.Hard tissue or bone.A capa is not necessary.

Event Description

It was reported that there was an issue with the product carbon steel scalpel blades # 15.The scalpel blade broke while cutting the oral mucosa during wisdom tooth extraction.The fragment fell into the throat but could be removed.No harm to patient reported.(b)(4).

• Brand Name: CARBON STEEL SCALPEL BLADES #15
• Type of Device: SCALPEL BLADES
• 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: kerstin rothweiler ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 8901674
• MDR Text Key: 154626980
• Report Number: 9610612-2019-00545
• Device Sequence Number: 1
• Product Code: GES
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: BB515
• Device Catalogue Number: BB515
• Device Lot Number: 4510041066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/18/2019
• Initial Date FDA Received: 08/16/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1