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

Model Number BB515

Device Problem Material Integrity Problem (2978)

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

Event Date 04/15/2021

Event Type  malfunction  

Manufacturer Narrative

Manufacturer evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.

Event Description

It was reported to aesculap ag that a carbon steel scalpel blades #15 (part # bb515) was used during an unknown procedure performed on (b)(6) 2021.According to the complainant, while performing surgery on hard tissues, capsule and tendon, the physician noted that the blade lost the cutting edge too fast.The complaint device has not been returned to the manufacturer for evaluation.No patient complication were reported as a result of the event.Although requested, additional information has not been made available.The malfunction is filed under (b)(4).

Manufacturer Narrative

Investigation results: as of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.Batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.In the event that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.Based upon the investigations results a capa is not necessary.

• Brand Name: CARBON STEEL SCALPEL BLADES #15
• Type of Device: BLADE, SCALPEL
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11987576
• MDR Text Key: 256014022
• Report Number: 9610612-2021-00443
• Device Sequence Number: 1
• Product Code: GES
• UDI-Device Identifier: 04038653338429
• UDI-Public: 4038653338429
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/04/2021

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
• Device Operator: Health Professional
• Device Model Number: BB515
• Device Catalogue Number: BB515
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/14/2021
• Initial Date FDA Received: 06/11/2021
• Supplement Dates Manufacturer Received: 07/14/2021
• Supplement Dates FDA Received: 08/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1