MAUDE Adverse Event Report: AESCULAP AG CARBON STEEL SCALPEL BLADES #15

Model Number BB515

Device Problems Break (1069); Material Integrity Problem (2978)

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

Event Date 02/15/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: the broken scalpel was not returned for investigation.A review of the device quality and manufacturing history records was not possible because the lot number is unknown.Based on the information available as well as a result of the investigation the root cause of the failure is most probably related to an insufficient usage.Based on the quality standards excluded a material or manufacturer caused error.The breakage occurred due to a mechanical overload situation.A capa is not necessary.Corrections added: lot # bb515.Device not returned.

Event Description

(b)(6).Breakage of half the blade during the incision of about 1cm in a knee in arthroscopy.It remains inside the tissues for which it has had to expand the incision and recover the piece to remove it.All med watch submissions related to this report are: 9610612-2018-00104, 9610612-2018-00105, 9610612-2018-00106.

• Brand Name: CARBON STEEL SCALPEL BLADES #15
• 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
• MDR Report Key: 7325387
• MDR Text Key: 101997458
• Report Number: 9610612-2018-00105
• 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: 03/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: BB515
• Device Catalogue Number: BB515
• Device Lot Number: 4508429956
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/01/2018
• Device Age: 11 MO
• Date Manufacturer Received: 02/16/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/11/2017
• 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