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

Model Number BB511

Device Problems Delivered as Unsterile Product (1421); Tear, Rip or Hole in Device Packaging (2385)

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 that the packaging of the individual blades have a hole in it.As a result the blades are no longer sterile.

Manufacturer Narrative

Investigation: the investigation was carried out using a keyence vhx-5000 digital microscope.Small holes can be found.Batch history review: the device quality and manufacturing history records have been checked for the available lot number.The device history files 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.Conclusion and root cause: based on the information available as well as a result of our investigation, the root cause of the failure is most probably related to an improper storage or transport of the product.Rational: according to the device history report, the product has been distributed in a condition complying with our specification.Most likely the product was damaged by an improper transport or storage.It is not clear when this damage occurred exactly.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: 6062069
• MDR Text Key: 58607567
• Report Number: 2916714-2016-00900
• Device Sequence Number: 1
• Product Code: GES
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2016
• 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: 4506730195
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 10/18/2016
• Device Age: 15 MO
• Date Manufacturer Received: 09/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other