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

Model Number BB511

Device Problem Corroded (1131)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.

Event Description

Country of complaint: (b)(6).It was reported the when the package was opened there was no rust on the blade.After using it on a patient, there was rust found on the blade.

Manufacturer Narrative

Investigation: due to the circumstances that we did not receive any products, an analytical investigation is not possible.As seen on pictures, the blade holder is manufactured by swann morton.According to information found on the manufacturers website, the blade handles used to be made of a nickel alloy.Batch history review: the device quality and manufacturing history records have been checked for all available lot numbers and found to be according to specifications valid at the time of production.Conclusion and root cause: based on available information as well as the provided pictures we assume a related root cause.Rational: the yellowish shade of the handle is an indication for the possibility that the handle is made of a nickel alloy.Referring to electrochemical series nickel is more precious than iron of the carbon-steel alloy of the blade.Corrosion in contact-area between both materials with blood as electrolyte is possible.No capa is 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
• 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: 6535471
• MDR Text Key: 74162970
• Report Number: 9610612-2017-00206
• Device Sequence Number: 1
• Product Code: GES
• Combination Product (y/n): N
• Reporter Country Code: MY
• 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,Followup
• Report Date: 08/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: BB511
• Device Catalogue Number: BB511
• Device Lot Number: M7463943
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 04/17/2017
• Date Manufacturer Received: 02/22/2017
• 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
• Patient Outcome(s): Other