MAUDE Adverse Event Report: MICROVISION, INC. CHANDELIER FIBER PROBE WITH ADJUSTIABLE RING, 25G; FIBER OPTIC ENDOILLUMINATION PROBE

Catalog Number 5316

Device Problem Melted (1385)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

In initial correspondence with (b)(4), the following was stated: "at the tip of the light of the laser probe a melting has occurred." (b)(4) requested to return the article for investigation and mvi assigned (b)(4) for the return, requesting that the device be returned in appropriate biohazardous packaging after confirming that the device was used in surgery and resulted in no patient harm.Further information provided by (b)(4) on 15jan2019 indicated that the lot number of the defective device is 1807120.Mvi asked (b)(4) for clarification on how the device was used and for clarification on the "laser probe" that was mentioned.(b)(4) was informed that "the fiber is a plastic one, and can only be used as an illumination fiber and not a laser fiber.While some plastic fibers may be used in a laser probe (with dual function), if used incorrectly (i.E.For photocoagulation via energy source vs.For endo illumination via light source), the fiber would melt.A glass fiber must be used for photocoagulation via energy source (laser)." (b)(4) responded, stating "the doctor has connected it as usual to the light source (as usual) and it is inserted into the eye via cannula", but did not remark on the laser probe that was mentioned in the original complaint statement.Upon receipt of the returned device on 22jan2019, it was identified that the unit was not returned in appropriate packaging for biohazardous material, as requested.Due to the biohazard risk the device could not pose because of its use during surgery, mvi elected no to open the packaging.Through a physical investigation under microscope could not be conducted, the device was visually inspected through the clear side of the pouch it was provided in.The inspection confirmed that there is clear melted/burning at the tip of the fiber, evident by a blackened, bulbous tip, in lieu of a clear, tapered per product specification.

Event Description

Distributor (b)(4) reported that an end-user customer complained about one (1) chandelier fiber (5316) which melted/burned at the tip during use, resulting in device malfunction, but no patient harm.The customer mentioned a laser probe in their statement, but it is unclear what this means, since the fiber is neither part of a laser probe nor intended for use with a laser probe.Mvi has attempted to clarify with (b)(4), but has received no clear response on the matter.(b)(4) has been instructed to return the malfunctioning device to mvi in proper biohazardous packaging for evaluation under (b)(4).

• Brand Name: CHANDELIER FIBER PROBE WITH ADJUSTIABLE RING, 25G
• Type of Device: FIBER OPTIC ENDOILLUMINATION PROBE
• Manufacturer (Section D): MICROVISION, INC.; 20 london lane; seabrook NH 03874
• Manufacturer (Section G): MICROVISION, INC.; 20 london lane; seabrook NH 03874
• Manufacturer Contact: matthew carignan ; 20 london lane; seabrook, NH 03874
• MDR Report Key: 9147283
• MDR Text Key: 219210487
• Report Number: 1226011-2019-00001
• Device Sequence Number: 1
• Product Code: FFS
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial

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?: No
• Device Operator: No Information
• Device Catalogue Number: 5316
• Device Lot Number: 1807120
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/02/2019
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: N
• Patient Sequence Number: 1