MAUDE Adverse Event Report: AESCULAP AG VENTRICULAR CANNULA DANDY

Model Number FF124R

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/06/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation results: initial reporter indicated six devices of the same lot number exhibited the reported sharp edge at the drill hole/perforation.Six devices were returned for investigation.Three were in an open and used condition, the other three were returned unused in the original package.The three opened devices all have different manufacture dates, which indicates they are from different lots and none of them share the same manufacture date / lot number of the products returned in package (all three packaged are from same lot number).The device related to this medwatch report was visually and microscopically investigated.It was determined that this device displayed no visible damage.Latex examination gloves were used to test to determine if sharp edge existed, the gloves were not damaged.The lot number of this device was not provided, therefore, review of device history records for this lot number could not be completed.Review of device quality and manufacturing records were checked for the reported lot number (4509784027) and were found to be according to specification valid at the time of production.No similar incidents were reported for this batch number.

Event Description

It was reported that a surgeon has 6 ventricular cannulas that have a sharp edge at the drill hole / perforation that could lead to brain tissue injury when the cannula is retracted.There was no patient injury associated with these devices.All are reported as the same lot/batch number.All medwatch reports associated with this report include: 9610612-2018-00611 ; 9610612-2018-00622; 9610612-2018-00623 ; 9610612-2018-00624 (this report) unopened product.9610612-2018-00625 9610612-2018-00626.

• Brand Name: VENTRICULAR CANNULA DANDY
• Type of Device: CANNULA
• 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: 8206729
• MDR Text Key: 131919084
• Report Number: 9610612-2018-00624
• Device Sequence Number: 1
• Product Code: HCD
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 12/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FF124R
• Device Catalogue Number: FF124R
• Device Lot Number: 4509784027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2018
• Distributor Facility Aware Date: 12/18/2018
• Device Age: 6 MO
• Date Manufacturer Received: 12/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1