MAUDE Adverse Event Report: AIRGAS THERAPEUTICS LLC ISPAN SULFUR HEXAFLUORIDE (SF6) GAS; INTRAOCULAR GAS

Catalog Number	8065797004
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported that ophthalmic operating console was not dispensing sulphur hexafluoride gas and gas bubble in patient eye was reduced to unusual size it was noticed on post operative day eight.There were no details of the procedure.There was no report of the patient harm.Additional information has been requested none received till date.
Additional Manufacturer Narrative
A check of the batch production record could not be performed because the lot number was not reported.The expiration date could not be determined.A check of the complaint records could not be performed because the lot number was not provided.A check of confirmed complaints for sf6 eye gas not lasting as long in the patient's eye as expected showed no complaints.The sample was not returned.Testing could not be performed.No sample was returned for evaluation.With no additional, related information provided, the reported event was not confirmed.At this time, the root cause of the reported event cannot be determined.Manufacturer will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).

• Brand Name: ISPAN SULFUR HEXAFLUORIDE (SF6) GAS
• Common Device Name: INTRAOCULAR GAS
• Manufacturer (Section D): AIRGAS THERAPEUTICS LLC; 6141 easton road; p.o. box 310; plumsteadville PA 18949
• Manufacturer (Section G): AIRGAS THERAPEUTICS LLC; 6141 easton road; p.o. box 310; plumsteadville PA 18949
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 16643265
• Report Number: 2518435-2023-00007
• Device Sequence Number: 6097390
• Product Code: LPO
• UDI-Device Identifier: 00380657970049
• UDI-Public: 00380657970049
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P900067
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 8065797004
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/03/2023
• Supplement Date Received by Manufacturer: 06/02/2023
• Initial Report FDA Received Date: 03/30/2023
• Supplement Report FDA Received Date: 06/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CONSTELLATION VISION SYSTEM.; CONSTELLATION VISION SYSTEM.
• Patient Sex: Unknown