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

Model Number BB511

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 11/21/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going, device not returned.

Event Description

Country of complaint: (b)(6).The blades #11 do not adapt to the cable, the blade enters with great difficulty and when it is withdrawn, it breaks down completely, causing a risk of accidental cutting.

• 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
• MDR Report Key: 7114397
• MDR Text Key: 94936860
• Report Number: 9610612-2017-00612
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: BB511
• Device Catalogue Number: BB511
• Device Lot Number: 4508304725
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/05/2017
• Device Age: 9 MO
• Date Manufacturer Received: 11/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2017
• 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