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

Model Number BB515

Device Problem Dull, Blunt (2407)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/29/2019

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with scalpel blade.Intraoperatively the cutting performance of the blade decreased, which resulted in the fact that the surgeon had to use several replacements.No patient harm was reported.Additional information was not provided.(b)(4).

Manufacturer Narrative

Manufacturing site evaluation: the product has been received in a unused, unopened and sterile status.According to the available information, there were no negative consequences for the patient.According to the information from the complaint we assume, that this is a scalpel which is part of the batch used in the reported surgery.Investigation: vigilance investigator carried out the pictorial documentation visually and microscopically.The scalpel has been found without any visual deviation or damages.The shape of the blade is according to the specifications.The cutting edge does not show any blunt part, this can be recognized by reflection of the light, on its whole length.Batch history review the device quality and manufacturing history records have been checked for the lot number (4509554087) and found to be according to the specification, valid at the time of production.No similar incidents have been filed with products from this batch.Conclusion and root cause 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.Rationale according to our investigation, the implemented quality standards and the review of the dhr files, a material defect and production error can be excluded.As no product deviation could be detected, most probably the insufficient cutting performance is related to circumstances during surgery.Capa is not necassary.

• Brand Name: CARBON STEEL SCALPEL BLADES #15
• Type of Device: SCALPEL BLADES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 8892814
• MDR Text Key: 154267913
• Report Number: 9610612-2019-00542
• Device Sequence Number: 1
• Product Code: GES
• 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: 10/29/2019

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
• Device Lot Number: G9554082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2019
• Initial Date Manufacturer Received: 07/16/2019
• Initial Date FDA Received: 08/14/2019
• Supplement Dates Manufacturer Received: 09/28/2019
• Supplement Dates FDA Received: 10/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1