MAUDE Adverse Event Report: ALPHA OMEGA ENGINEERING LTD. ALPHA OMEGA; STERILE DISPOSABLE CANNULA

Model Number	TAPERED
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/31/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Alpha omega's disposable sterile cannula for neurosurgery, model: tapered cannula (pn str-000076-10) was used during a routine placement of a dbs electrode neurosurgery procedure.Following the neurosurgery, the user complained that he noticed unusual hemorrhage which he suspects that was caused by the use of alpha omega's disposable sterile cannula.No other adverse neurosurgery outcomes were reported.No remedial action was reported by the healthcare facility.
Event or Problem Description
Alpha omega's disposable sterile cannula for neurosurgery, model: tapered cannula (pn: str-000076-10) was used during a routine placement of a dbs electrode neurosurgery procedure.Following the neurosurgery, the user complained that he noticed unusual hemorrhage which he suspects that was caused by the use of alpha omega's disposable sterile cannula.No other adverse neurosurgery outcomes were reported.No remedial action was reported by the healthcare facility.
Additional Manufacturer Narrative
Disposable tapered cannula (pn: str-000076-10) investigation included: nine (9) neurosurgery centers in europe, one (1) center in canada and one (1) center in usa are routinely using the tapered cannula.All, with the exception of inselspital-schuepbach (subject to this report) were not facing unusual brain hemorrhage while using the tapered cannula.Retesting sampled tapered cannulas (pn: str-000076-10) from finished goods stock.Consulting with 4 neurosurgeons about possible causes that may cause severe brain hemorrhage during dbs procedure.All neurosurgeons routinely use alpha omega cannulas (two are using the same cannula model).Analysis results: all cannulas passed test criteria but small percentage of the retested cannulas, from lot#: 30106, demonstrated marginal results in straightness test criteria, which according to the neurosurgeons, may not be the cause for brain hemorrhage.According to the neurosurgeons planning inexactness is the main cause for hemorrhage.Note: the tapered cannula is the thinness in diameter, therefore is sensitive to handling and shipping conditions.Actions taken by alpha omega: remedial action: 1.Recall is not relevant since the tapered cannulas (pn: str-000076-10, lot#: 30106) are not in the field anymore, alpha omega contacted the users of the tapered cannula and found that the cannulas (pn: str-000076-10, lot#: 30106) 2.Improving the straightness test by using automated tool and reducing acceptance range.Corrective action: review and as appropriate, improve the tapered cannula handling processes (i.E.Cleaning, packaging, storage and shipping) in order to improve preservation of the product.

• Brand Name: ALPHA OMEGA
• Common Device Name: STERILE DISPOSABLE CANNULA
• Manufacturer (Section D): ALPHA OMEGA ENGINEERING LTD.; mount precipice; nazareth, 16121 02; IS 1612102
• MDR Report Key: 7306330
• Report Number: 9615126-2018-00001
• Device Sequence Number: 1067107
• Product Code: GZL
• UDI-Device Identifier: 07290014954731
• UDI-Public: (01)07290014954731(17)191206(10)30106
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K120098
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Remedial Action: Modification/Adjustment,Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/06/2019
• Device Model Number: TAPERED
• Device Catalogue Number: STR-000076-10
• Device Lot Number: 30106
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/31/2018
• Supplement Date Received by Manufacturer: 01/31/2018
• Initial Report FDA Received Date: 03/01/2018
• Supplement Report FDA Received Date: 04/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other