MAUDE Adverse Event Report: MICROVISION, INC. 25GA. BRUSH-TIP CANNULA

Catalog Number 5160

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Manufacturer Narrative

Device history record/lot review: upon review of the device history record no evidence of an issue that contributed to the reported complaint was identified.It was found that this lot met all specifications outlined for release.To date, this is the first reported complaint of this nature; this complaint is thus treated as an isolated incident.This reportable event was identified during a voluntary retrospective review of all complaints since 2015 by the manufacturer (microvision, inc.).There is no further information available and no sample was returned; all information has been disclosed.This complaint has now been closed.

Event Description

An event has been reported by a distributor in (b)(6).The following was reported: the silicone brush tip came off and dropped into the patient's eye during surgery.The surgeon could not feel any resistance in his hand as the cannula was inserted into the trocar.After the cannula was inserted into the eye, the surgeon found that the cannula did not have the silicone tip.The surgeon subsequently found the silicone tip in the eye and safely removed the tip with forceps.The surgeon successfully completed the surgery with another brush-tip cannula.

• Brand Name: 25GA. BRUSH-TIP CANNULA
• Type of Device: 25GA. BRUSH-TIP CANNULA
• Manufacturer (Section D): MICROVISION, INC.; 20 london lane; seabrook NH 03874
• Manufacturer (Section G): MICROVISION, INC.; 20 london lane; seabrook NH 03874
• Manufacturer Contact: tatsiana yarashevich ; 20 london lane; seabrook, NH 03874 ; 6034745566
• MDR Report Key: 7344818
• MDR Text Key: 102626388
• Report Number: 1226011-2018-00001
• Device Sequence Number: 1
• Product Code: HMX
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 09/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: 5160
• Device Lot Number: 1906158
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention