MAUDE Adverse Event Report: AESCULAP AG CARBON STEEL SAFETY SCALPEL #23; DISPOSABLE SCALPELS

Model Number	BA823SU
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 ba823su - carbon steel safety scalpel #23.According to the complaint description, the blade retracts during incision.The scalpel does not hold in open position.The patient harm is unknown.Additional information has been requested but not yet received as of this report.The malfunction is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Based on the investigation results, this event was re-evaluated and is considered no longer reportable - no malfunction or serious injury.

• Brand Name: CARBON STEEL SAFETY SCALPEL #23
• Common Device Name: DISPOSABLE SCALPELS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11445479
• Report Number: 9610612-2021-00144
• Device Sequence Number: 3853077
• Product Code: GDX
• UDI-Device Identifier: 04046963510749
• UDI-Public: 4046963510749
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2021

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: 07/26/2025
• Device Model Number: BA823SU
• Device Catalogue Number: BA823SU
• Device Lot Number: 4511842912
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/08/2021
• Supplement Date Received by Manufacturer: 04/30/2021
• Initial Report FDA Received Date: 03/09/2021
• Supplement Report FDA Received Date: 05/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1