MAUDE Adverse Event Report: AESCULAP AG CARBON STEEL SCALPEL BLADES #11

Model Number BB511

Device Problem Dull, Blunt (2407)

Patient Problem No Information (3190)

Event Date 04/24/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

Information received by notivisa - an automated system for receipt of adverse events in (b)(6).Limited information, including details of the incident were provided.Information received indicates that the scalpel blades did not cut during use.Five material / lot number combinations were provided.All medwatch reports associated with the report from notivisa include the following: 9610612-2018-00443 (this report), 9610612-2018-00444, 9610612-2018-00445, 9610612-2018-00446, 9610612-2018-00447.

Manufacturer Narrative

All medwatch reports associated with this report: 9610612-2018-00443, 9610612-2018-00444, 9610612-2018-00445, 9610612-2018-00446, 9610612-2018-00447.Investigation: no product is at hand.Batch history review: the device quality and manufacturing history records have been checked for all the lot numbers (4508507992/4508827131/4508948992) 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: no product available and therefore it is hardly possible to determine an exact conclusion and root cause.We assume that the cause of the failure is not product related.There is the possibility that the root cause of the problem is most probably usage related.Rationale: unfortunately, due to a lack of data and without the product we can not determine the exact cause.According to the quality standard and dhr files, a material defect or production error can be excluded.There is the possibility for a usage error.No capa is necessary.

• Brand Name: CARBON STEEL SCALPEL BLADES #11
• Type of Device: SCALPEL BLADE
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 7916611
• MDR Text Key: 122011991
• Report Number: 9610612-2018-00443
• 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: foreign,other
• Type of Report: Initial,Followup
• Report Date: 11/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: BB511
• Device Catalogue Number: BB511
• Device Lot Number: 4508507992
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/21/2018
• Device Age: 11 MO
• Date Manufacturer Received: 10/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1