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

Model Number BB515

Device Problem Failure to Cut (2587)

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

Event Date 05/10/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.

Event Description

Country of complaint: (b)(6).While performing surgery, the aforementioned leaves did not cut cartilage, it even cost them to cut skin.It had to use 14 sheets to achieve the goal.Consequences of non-compliance: 14 sheets cannot be loaded to the patient, surgeon non-compliance wo requires changing supplier, process performed without necessary quality.Also, please note that this fact had already occurred in isolation in two surgeries.

Manufacturer Narrative

Investigation three surgical blades arrived in a clean status without visible damage and two others in closed dispenser packaging.A visual and microscopic inspection was performed.The visual inspection made on the first blade where visible damaged cutting edge was found.Additionally unknown deposits were also found, in additional to brown discolorations and the surgical blade is bent.Visual inspection of the second surgical blade found visible damaged cutting edge, along with unknown deposits and the surgical blade was bent.Visual inspection of the third surgical blade also found a visible damaged cutting edge and unknown deposits.No more visible damage was found at the cutting edge.The closed dispenser packaging was opened and a visual inspection of an unused surgical blade.No visible failure was found.Batch history review the device quality and manufacturing history records have been checked for all the lot numbers (4508823501/4508804701) and found to be according to the specification, valid at the time of production.No similar incidents have been filed with products from these batches.Conclusion and root cause the root cause of the problem is most probably usage related.Rationale according to the quality standard and dhr files a material defect and production error can be excluded.Investigations lead to the assumption that the visible damages and the bent surgical blades were caused by an improper handling.There is the possibility of leverage with the surgical blades and these will result in bent blades.Additionally, according to the global marketing general open surgery the surgical blades are not intended to cut cartilage.We assume that the discolorations are unknown residues.No capa 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: 7687220
• MDR Text Key: 113969622
• Report Number: 9610612-2018-00306
• 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: 12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2018
• 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: 4508823501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2018
• Distributor Facility Aware Date: 08/23/2018
• Device Age: 9 MO
• Date Manufacturer Received: 08/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other