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

Model Number BB515

Device Problems Failure to Cut (2587); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.Device not returned.

Event Description

(b)(6).It was reported that the blade did not cut.

Manufacturer Narrative

Investigation: no product is at hand.Batch history review: the device history records have been checked and found to be according to the specification, valid at the time of production.There is no indication for a material failure or a manufacturing defect.No further complaint registered against the same batch number.Conclusion and root cause: based on the information available, the root cause of the failure is most probably related to an insufficient usage.Rational: based on the quality standards, we exclude a material or manufacturer caused error.It is possible that an insufficient usage resulted in the described failure.No capa is necessary.

• 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: 7434522
• MDR Text Key: 105691281
• Report Number: 9610612-2018-00187
• 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: 07/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: BB515
• Device Catalogue Number: BB515
• Device Lot Number: 4508746528
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/09/2018
• Device Age: 1 YR
• Date Manufacturer Received: 03/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other