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

Model Number BB511

Device Problems Contamination /Decontamination Problem (2895); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/27/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: this instrument is not available for investigation.According to the available information, there were no negative consequences for the patient.The device quality and manufacturing history records have been checked for the lot number and found to be according to the specification, valid at the time of production.No similar incidents have been filed with products from this batch.No product available and therefore it is hardly possible to determine an exact conclusion and root cause.It is assumed 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.A capa is not necessary.

Event Description

It was reported by the healthcare professional to the company sales representative "during surgery when the blade was opened it appeared to have rust and dirt on it.

• Brand Name: CARBON STEEL SCALPEL BLADES #11
• Type of Device: SCALPEL BLADES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 7996601
• MDR Text Key: 125612616
• Report Number: 9610612-2018-00477
• Device Sequence Number: 1
• Product Code: GES
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2018
• 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: Y9021051
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/10/2018
• Date Manufacturer Received: 09/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1