MAUDE Adverse Event Report: AESCULAP AG VENTRICULAR CANNULA CUSHING-CAIRNS; MICRO NEUROSURGICAL INSTR. / D

Model Number FF126R

Device Problem Sharp Edges (4013)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/19/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).When additional information is received a follow up report will be submitted.

Event Description

It was reported by the healthcare professional "that the cannula had sharp edges." there was no patient injury reported.

Manufacturer Narrative

Investigation: the investigation was carried out pictorally and microscopically.According to the test plan, the instrument must be free of sharp edges.Batch history review: the device quality an manufacturing history records have been checked for the available lot number and found to be according to our specifications valid at the time of production.No similar incidents have been filed with products from this batch.Conclusion and root cause: based on the information available as well as a result of our investigation, the product is according to the specification valid at the time of production.Rationale: the provided cannula is according to the specification, nevertheless in this case, the edges of the opening is against 0mm radius and it feels sharp.Thus, the cannula is not according to the test plan and an injury is possible.A product safety case will be initiated.

• Brand Name: VENTRICULAR CANNULA CUSHING-CAIRNS
• Type of Device: MICRO NEUROSURGICAL INSTR. / D
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 8404858
• MDR Text Key: 138277735
• Report Number: 9610612-2019-00170
• Device Sequence Number: 1
• Product Code: HCD
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 03/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FF126R
• Device Catalogue Number: FF126R
• Device Lot Number: 4507673115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2019
• Distributor Facility Aware Date: 03/12/2019
• Device Age: 32 MO
• Date Manufacturer Received: 03/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1