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

Model Number BB511

Device Problem Material Integrity Problem (2978)

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

Event Date 10/22/2020

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 scalpel blade no.11 bbraun (lot: k9356329), presents loss of the wire in advance, requiring extra consumption.There was no described patient harm.Additional information was not provided nor available / was not available.Additional patient information is not available.The adverse event / malfunction is filed under (b)(4).

Manufacturer Narrative

Investigation results: as of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.Batch history review: due to the lack of onformation it is not possible to checked the device history records.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.In the event that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.Based upon the investigations results a capa is not necessary.

• Brand Name: CARBON STEEL SCALPEL BLADES #11
• Type of Device: GENERAL SURGICAL INSTRUMENTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11398726
• MDR Text Key: 249477296
• Report Number: 9610612-2021-00112
• 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: 07/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2021
• 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: K9356329
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1