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).

• Brand Name: CARBON STEEL SCALPEL BLADES #15
• Type of Device: BLADE, SCALPEL
• 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: 11987576
• MDR Text Key: 256014022
• Report Number: 9610612-2021-00443
• Device Sequence Number: 1
• Product Code: GES
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/04/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 06/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: BB515
• Device Catalogue Number: BB515
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial