MAUDE Adverse Event Report: AESCULAP AG SENSATION MICRSCIS S/S BAY CVD 120/245MM; MICRO-NEURO INSTRUMENTS

Model Number FM125R

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

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

Event Date 06/15/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: according to the available information, there were no negative consequences for the patient.The pair of scissors is broken at the connection screw.Two handle parts and one blade fragments are available for investigation.The investigation was carried out visually.The device quality and manufacturing history records have been checked for the available lot number.The device history has been checked and found to be according to specifications valid at the time of production.No similar incidents have been filed with products from this batch.Based on the information available as well as a result of the investigation the root cause of the failure is most probably elated to insufficient usage.A capa is not necessary.

Event Description

Country of complaint: (b)(6).It was reported that the customer complains that in the sterile procesign department the metal part of the scissor broke at the point where the screw is.This is the 2nd time this has happened.No surgical delays and no patient injury reported.

• Brand Name: SENSATION MICRSCIS S/S BAY CVD 120/245MM
• Type of Device: MICRO-NEURO 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
• MDR Report Key: 7716365
• MDR Text Key: 115109215
• Report Number: 9610612-2018-00341
• Device Sequence Number: 1
• Product Code: GZX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FM125R
• Device Catalogue Number: FM125R
• Device Lot Number: 52109277
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2018
• Distributor Facility Aware Date: 07/23/2018
• Device Age: 3 YR
• Date Manufacturer Received: 06/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2015
• 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