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

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

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 bb511 - carbon steel scalpel blades #11.According to the complaint description, the sharpness oft the scalpel blade no.11 is not upto the mark from the beginning oft the or procedure.Blade is blunt.There was no described patient harm.Additional information was not provided nor available / was not 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.We cannot detect any visible damage to the cutting edge and cannot determine the exact cause for the mentioned deviation.For a damaged cutting edge or loss of cutting ability, there is a possibility that not only tissue, but e.G.Bone or similar was cut or prepared.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.

• Brand Name: CARBON STEEL SCALPEL BLADES #11
• Type of Device: BASIC INSTRUMENTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11733888
• MDR Text Key: 266754310
• Report Number: 9610612-2021-00336
• Device Sequence Number: 1
• Product Code: GES
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/11/2021

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: 4511956573
• 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