MAUDE Adverse Event Report: VISION-SCIENCES, INC. BLS-100 LED LIGHT SOURCE / BLS-1000 PORTABLE; BLS-1000 LED LIGHT SOURCE SET

Catalog Number 07-3053-AUS

Device Problems Battery Problem (2885); Charging Problem (2892)

Patient Problem No Patient Involvement (2645)

Event Date 05/21/2014

Event Type  malfunction  

Event Description

On (b)(6) 2014, vision-sciences inc received a report, from distributor in (b)(6), that one light source bls-1000 (p/n 07-3050) has exploded when switched on.There was no patient involved but the nurse preparing the unit was slightly burnt at hand and eye.

Manufacturer Narrative

Although no adverse health consequences have been reported for any of the complaints, user (nurse) received a minor thermal burn, despite the extreme low occurrence rate for this event ((b)(4)).Initial investigation suggests incompatibility between the charger and battery; however, testing is still being performed to confirm initial conclusion.Non-conforming report issued to chargers to quarantine all charges in stock.Hold-shipment status has been placed on chargers.Expected date for completion of additional testing (failure mode) july 15th, 2014.Initial root cause investigation performed on 06/06/2014 indicated the following: device - accessory: bls-1000: the remains of the bls-1000, batteries and charger were examined by engineering on 06/02/2014.Remains of bls-1000 (body) were still operational.Close examination of the remains of the bls-1000 body show shred metal severely fractured indicating intense pressure build-up inside the bls-1000 body resulting in the rupture of the battery compartment with expulsion of the battery and the contents.Accessories: battery charger and lithium-ion rechargeable batteries: battery charger was examined and was found to be operating normally.Conclusion: the battery was over-charged by the vanson v-95 charger.Charger has been found not adequate to handle the charge for this battery (eemb lir 17335).Battery specification calls for charge upper limit voltage of 4.2 v and the vanson charger upper limit voltage is 4.45.Internal (b)(4) assigned to the case (currently in investigation stage).Additional testing is being performed to determine remedial action.Expected date for completion of additional testing (failure mode) july 15th 2014.

• Brand Name: BLS-100 LED LIGHT SOURCE / BLS-1000 PORTABLE
• Type of Device: BLS-1000 LED LIGHT SOURCE SET
• Manufacturer (Section D): VISION-SCIENCES, INC.; 40 ramland rd. south; orangeburg NY 10962
• Manufacturer Contact: 40 ramland rd. south; orangeburg, NY 10962 ; 8453650600
• MDR Report Key: 3928198
• MDR Text Key: 4600105
• Report Number: 2242464-2014-00001
• Device Sequence Number: 1
• Product Code: EOB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K050972
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07-3053-AUS
• Other Device ID Number: 00874485002091
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 06/02/2014
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1