MAUDE Adverse Event Report: AIR LIQUIDE ISPAN SULFUR HEXAFLUORIDE (SF6) GAS; INTRAOCULAR GAS

Catalog Number 8065797005

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/17/2020

Event Type  malfunction  

Manufacturer Narrative

No sample or lot number information 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 surgeon reported that an ophthalmic gas was resorbing more quickly inside of the patient's eye than it used to.No patient harm was reported.Additional information has been requested.

Manufacturer Narrative

An ophthalmic gas sample was received and put through final inspection and testing.There was no problem found with the sample related to the reported event.The product met specifications upon sample testing.A review of the batch production record for the reported lot was performed and confirmed the product met specifications at the time of release.A review of complaints for the last 12 months did not indicate any additional related reports for this reported lot number of ophthalmic gas.No problem was found with the ophthalmic gas sample therefore, the root cause of the reported event cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The previous report submitted for this event contained an error in h1: ¿summary report¿ was inadvertently selected.After a recent systems update, a system error caused the inadvertent additional selection of ¿summary report¿ in h.1.On a select number of reports.The error, which was limited only to the h.1.Field, was promptly identified and quickly rectified.Correction smdrs are being filed for the impacted reports.This smdr is correcting that error for this event.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

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

Event Description

Additional information received further clarified that 20% ophthalmic gas concentration mixed with room air was instilled into the patient's eye during their initial pars plana vitrectomy with endolaser surgery to treat a retinal detachment.The instilled bubble was only 55% of the anticipated size upon seven days post-op.The patient's current condition was reported as stable.

• Brand Name: ISPAN SULFUR HEXAFLUORIDE (SF6) GAS
• Type of Device: INTRAOCULAR GAS
• Manufacturer (Section D): AIR LIQUIDE; 13140 ti blvd.; dallas TX 75243
• MDR Report Key: 11071902
• MDR Text Key: 224410334
• Report Number: 1610287-2020-00040
• Device Sequence Number: 1
• Product Code: LPO
• Combination Product (y/n): N
• PMA/PMN Number: P900067
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: 8065797005
• Device Lot Number: 925609
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2021
• Date Manufacturer Received: 03/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 64 YR