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

Model Number BB511

Device Problem Dull, Blunt (2407)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/02/2021

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 #11 (part # bb511) was used during an unknown procedure performed on march 2, 2021.According to the complainant, the scalpel blade was blunt.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the event.Although requested, additional information has not been made available.The malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Based upon investigation results, this event was re-evaluated and is considered no longer reportable due to risk file- no malfunction or serious injury.The review of risk assessment revealed that the overall risk level (severity 2(5) probability of occurrence2(5)) according to din en iso 14971 is still acceptable.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 cutting edge was caused due to an improper handling.There is a possibility that not only tissue (e.G.Bone) was cut or prepared.We cannot determine the exact cause.Based on the feedback of manager r&d instruments & surfaces and of brochures "instrument reprocessing - reprocessing of instruments to retain value, investigations lead to the assumption that the mentioned deviations were caused by an usage-related deviation.Manufacturing evaluation: the device arrived in a clean state with dark and brown discolorations.The investigation was carried out visually and microscopically with the digital microscope vhx-5000 keyence.A visual inspection of the device identified trace of use on the cutting edge and detected a damaged cutting edge.Additionally, dark and brown discolorations were observed.The device quality and manufacturing history records (dhr) have been checked for all leading device(s) lot numbers and the products found to be according to our specification valid at the time of production.There are no similar complaints against the same lot number(s) with this error pattern.The most probable root cause was determined to be usage related.

• Brand Name: CARBON STEEL SCALPEL BLADES #11
• Type of Device: BLADE, SCALPEL
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11734922
• MDR Text Key: 253236270
• Report Number: 9610612-2021-00343
• Device Sequence Number: 1
• Product Code: GES
• UDI-Device Identifier: 04038653338399
• UDI-Public: 4038653338399
• 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: 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BB511
• Device Catalogue Number: BB511
• Device Lot Number: 4511854298
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2021
• Date Manufacturer Received: 09/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1