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

Catalog Number 8065797303

Device Problem Gas Output Problem (1266)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

No sample has 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.Additional information has been requested.The manufacturer internal reference number is: (b)(4).

Event Description

A health professional reported that an ophthalmic gas dispensing regulator would not release gas.Procedure details, patient involvement and patient impact information is unknown.Additional information has been requested.Additional information received confirmed that the gas regulator would not dispense gas during a retina surgery.An alternate regulator was obtained in order to complete the procedure.There was no impact to the patient.

Manufacturer Narrative

The customer's regulator was sent to the contract manufacturer for evaluation however, the sample has not yet been confirmed as received by the contract manufacturer.To date, no evaluation results have been received from the contract manufacturer.With no additional, related information provided, the customer reported event could not be confirmed.The root cause cannot be determined conclusively.Data will continue to be monitored for evidence of adverse trending with further action taken as appropriate.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Additional information is provided in sections d.10, g.1, g.2, h.3, h.6 and h.10.The regulator sample was received at the contract manufacturer's location in good condition.Per the contract manufacturer's evaluation, the returned regulator was put through final inspection and test where the regulator failed inspection for insufficient flow.The complaint was confirmed as the flow was far below specification.The regulator could not be adjusted to meet flow specifications.No obstructions could be found that would account for this.Although the reported event could be confirmed, the root cause could not be determined conclusively.A review of the batch production record for the reported lot number showed no unusual manufacturing issues.A review of the complaint records showed three previous complaints against the reported lot.The root cause cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).

• Brand Name: ISPAN GAS TANK REGULATOR
• Type of Device: INTRAOCULAR GAS
• Manufacturer (Section D): AIR LIQUIDE; 13140 ti blvd.; dallas TX 75243
• MDR Report Key: 8706921
• MDR Text Key: 148548741
• Report Number: 1610287-2019-00018
• Device Sequence Number: 1
• Product Code: LPO
• Combination Product (y/n): N
• PMA/PMN Number: P900066
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2019
• 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: 819708
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2019
• Date Manufacturer Received: 02/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ISPAN SF6 SULFUR HEXAFLUORIDE.