MAUDE Adverse Event Report: AESCULAP AG SCALPFIX APPLICATOR; MICRO NEUROSURGICAL INSTR. / D

Model Number FF012R

Device Problem Failure to Eject (4010)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The instruments are not available for investigation.Ff012r: the product does not require batch management; a review of the device quality and manufacturing history records is not possible.No product available and therefore it is hardly possible to determine an exact conclusion and root cause.We assume that the cause of the failure is not product related.There is the possibility that the root cause of the problem is usage or related to an improper transport or storage of the product.Due to a lack of data and without the product we cannot determine the exact cause.According to the quality standard a material defect and production error can be excluded.Due to the statement of the product manager global marketing - neurosurgery there is the possibility for the follow causes: ff0112r: spring force too low.The too low spring force of ff012r cold have been caused by a usage or maintenance error.There is the possibility of disassembly of the safety clip by an improper transport or storage of the product.Possibly there could have been too much friction in the magazine.

Event Description

It was reported that there was an intraoperative issue with the sterile scalpfix devices.During a craniotomy on (b)(6) 2018, the scalpfix reloads were noted as jamming.After every second clip was dispensed, the magazine jammed.The surgeon requested the non-disposable gun for application and the issue again occurred; a second disposable product was also opened.There was a delay in surgery of 20 minutes due to the malfunction.There was no other intervention required.No patient injury reported.All med watch submissions related to this patient are: 9610612-2019-00040 (this report), 9610612-2019-00020.

• Brand Name: SCALPFIX APPLICATOR
• Type of Device: MICRO NEUROSURGICAL INSTR. / D
• 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: 8294849
• MDR Text Key: 136987293
• Report Number: 9610612-2019-00040
• Device Sequence Number: 1
• Product Code: GDO
• 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,user f
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FF012R
• Device Catalogue Number: FF012R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/26/2018
• Initial Date Manufacturer Received: 01/18/2019
• Initial Date FDA Received: 01/31/2019
• 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