MAUDE Adverse Event Report: AESCULAP AG CARBON STEEL SCALPEL BLADES #20

Model Number BB520

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/01/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: the device quality and manufacturing history records have been checked for the available lot number.The device history file has been checked and found to be according to our specification valid at the time of production.No similar incidents have been filed with products from this batch.Based on the information available as well as a result of the investigation the root cause of failure is most probably user related.A material or production error is excluded.It is liable that a mechanical overload situation led to the breakage.Corrective/preventive actions: is not necessary.

Event Description

Country of complaints: (b)(6).The scalpel blade is broken and a part of it was recovered with difficulty from the surgical field.All med watch submissions related to this report are: 9610612-2017-00195, 9610612-2017-00196.

• Brand Name: CARBON STEEL SCALPEL BLADES #20
• 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: 6455145
• MDR Text Key: 71583856
• Report Number: 9610612-2017-00196
• Device Sequence Number: 1
• Product Code: GES
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: BB520
• Device Catalogue Number: BB520
• Device Lot Number: 4507635095
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/24/2017
• Device Age: 8 MO
• Date Manufacturer Received: 03/08/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/13/2016
• 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
• Patient Outcome(s): Other