MAUDE Adverse Event Report: AIR LIQUIDE ISPAN GAS TANK REGULATOR; INTRAOCULAR GAS

Catalog Number 8065797303

Device Problem Device Inoperable (1663)

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

Event Date 09/10/2015

Event Type  malfunction  

Manufacturer Narrative

A sample is available that has not yet been received by manufacturing for evaluation.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.(b)(4).

Event Description

A customer reported that an ophthalmic gas regulator valve was noted to have stopped working completely.There was no procedure or patient involvement.

Manufacturer Narrative

A review of the customer¿s complaint history for the last 24 months did not show any previous complaints of this kind against the system.A review of the manufacturing records did not reveal any related nonconformity during manufacturing for the reported product lot.Based on quality assurance assessment, the product met specifications at the time of release.One regulator sample was received and evaluated by the manufacturer.A visual assessment of the returned sample showed no abnormal visual nonconformity.The regulator gauge was able to measure 100 pounds per square in (psi) when connected to a 100 psi air source.However, when the regulator orifice was removed, no gas flow was observed.The on/off valve was removed and gas flow was observed.After troubleshooting the sample, a piece of plastic was found in the on/off valve which was blocking the flow.The root cause of the reported event can be attributed to the piece of plastic blocking the flow.However, how or when the plastic entered into the regulator valve cannot be determined conclusively.(b)(4).

• Brand Name: ISPAN GAS TANK REGULATOR
• Type of Device: INTRAOCULAR GAS
• Manufacturer (Section D): AIR LIQUIDE; 13140 ti blvd.; dallas TX 75243
• Manufacturer (Section G): AIR LIQUIDE; 13140 ti blvd.; dallas TX 75243
• Manufacturer Contact: eddie darton, md, jd ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175686660
• MDR Report Key: 5126659
• MDR Text Key: 27690374
• Report Number: 1610287-2015-00537
• Device Sequence Number: 1
• Product Code: LPO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P900066
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Followup
• Report Date: 11/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065797303
• Device Lot Number: 434316
• Other Device ID Number: 00380657973033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2014
• 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
• Patient Outcome(s): Other