MAUDE Adverse Event Report: AESCULAP AG IRIS SCISSORS CVD S/S 110MM; SURGICAL SCISSORS

Model Number BC111R

Device Problem Break (1069)

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

Event Date 12/29/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Country of complaint: (b)(6).During procedure, the tip of blade was broken.The breakage was found (b)(6) 2018.The customer was not sure that the breakage was caused during maintenance or procedure at the time of finding the breakage.As there was the possibility of remaining inside a patient, the customer checked and found that the broken tip was inside the patient who had ptosis surgery on (b)(6) 2017.According to x-ray, the broken tip was around orbit.The surgery to remove the broken tip is scheduled (b)(6) 2018.

Manufacturer Narrative

The investigation was carried out visually using a keyence vhx 5000 digital microscope.The device quality and manufacturing history records have been checked for the available lot number.The device history file 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.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 insufficient maintenance of the device.The corrosion on the pair of scissors is a so-called "stress-corrosion' in combination with a mechanical tension.Reprocessing the instrument in a state of high tension can speed up the defect.No capa is necessary.

• Brand Name: IRIS SCISSORS CVD S/S 110MM
• Type of Device: SURGICAL SCISSORS
• 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: 7232638
• MDR Text Key: 98786043
• Report Number: 9610612-2018-00040
• Device Sequence Number: 1
• Product Code: HNF
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 02/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BC111R
• Device Catalogue Number: BC111R
• Device Lot Number: 4508119663
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2018
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 01/16/2018
• Device Age: 1 MO
• Date Manufacturer Received: 01/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/27/2016
• 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