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

Catalog Number 8065797303

Device Problem Defective Device (2588)

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

Event Date 08/08/2018

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.(b)(4).

Event Description

A health professional reported that an ophthalmic gas dispensing regulator valve was defective and would not blow out.Procedure details, patient involvement and patient impact information is unknown.

Manufacturer Narrative

A review of confirmed complaints showed a spike in complaints for gas not coming out of regulators however, to date, no trend in these complaints has been observed.The root cause of the reported event 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

The manufacturer internal reference number is: (b)(4).

Event Description

Additional information received clarified that the dispensing regulator would not allow gas to exit during surgery.An alternate regulator was obtained in order to perform and complete the procedure.There was no impact to the patient.

Manufacturer Narrative

Per the contract manufacturer's completed investigation, a check of the batch production record for the reported lot number showed that the product met specifications at the time of release.With no sample returned and no additional, related information provided, the customer reported event was not confirmed.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: 7801460
• MDR Text Key: 133906115
• Report Number: 1610287-2018-00034
• 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,Followup
• Report Date: 06/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2018
• 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: 711606
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other