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

Model Number BB515

Device Problems Break (1069); Fracture (1260)

Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Date 11/16/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: the instrument arrived in a decontaminated condition and available for investigation.The broken fragment is missing.During a surgery the scalped blade broke off and the patient swallowed a fragment.This fragment could be retrieved endoscopically.Hereinafter another scalped blade was used and it broke off into pieces also.The swallowed fragment could be retrieved via gastroscopy and an additional anesthesia was not needed.The surgical blade arrived in a clean status with visible damage but without the broken off fragment.The components have been examined visually and microscopically with the digital microscope.A visual inspection of the instrument was performed and discoloration was found.Additional visual inspection was performed of the fracture surface.A light brown discoloration was found.The device quality and manufacturing history records have been checked for the lot number and found to be according to the specification, valid at the time of production.The root cause of the problem is most probably usage related.According to the quality standard and dhr files a material defect and production error can be excluded.The breakage was caused by a mechanical overload situation.There is a possibility for an improper handling.A capa is not necessary.

Event Description

(b)(6).During oral surgery the scalpel blade broke off and the patiet swallowed a fragment.This fragment could be retrieved endoscopically.Hereinafter another scalpel blade was used and it broke broke off into pieces also.

• 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: 7305778
• MDR Text Key: 101355647
• Report Number: 9610612-2018-00068
• Device Sequence Number: 1
• Product Code: GES
• Combination Product (y/n): N
• PMA/PMN Number: EXCEPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BB515
• Device Catalogue Number: BB515
• Device Lot Number: P8581576
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2018
• Distributor Facility Aware Date: 02/23/2018
• Date Manufacturer Received: 02/01/2018
• 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