MAUDE Adverse Event Report: AESCULAP AG CARBON STEEL SAFETY SCALPEL #23; SCALPEL, ONE-PIECE

Model Number	BA823SU
Medical Device Problem Code	Retraction Problem (1536)
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.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported to aesculap ag that a carbon steel safety scalpel #23 (part # ba823su) failed during use.According to the complainant, the io blade-failure during use.Reportedly, the primary packaging of the scalpel tore, causing a loss of sterilization.The complaint device was returned to the manufacturer for evaluation.There was no described patient harm.Additional information has not been made available.The malfunction is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2021-00197 ((b)(4) + ba823su), and 9610612-2021-00183 ((b)(4) + ba823su).
Additional Manufacturer Narrative
Based upon new information received, this event was re-evaluated and is considered no longer reportable: no malfunction or serious injury.
Event or Problem Description
The malfunction is filed under aag reference (b)(4) ((b)(4)).

• Brand Name: CARBON STEEL SAFETY SCALPEL #23
• Common Device Name: SCALPEL, ONE-PIECE
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11520064
• Report Number: 9610612-2021-00184
• Device Sequence Number: 3678757
• 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): 05/25/2021

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: 09/21/2025
• Device Model Number: BA823SU
• Device Catalogue Number: BA823SU
• Device Lot Number: 4511979495
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2021
• Supplement Date Received by Manufacturer: 02/18/2021
• Initial Report FDA Received Date: 03/18/2021
• Supplement Report FDA Received Date: 05/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1