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

Catalog Number	8065797005
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Retinal Injury (2048)
Date of Event	05/01/2021
Type of Reportable Event	Serious Injury
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 following a vitrectomy procedure two patient's experienced retinal damage.Additional information has been requested but not received.This report represents patient one of two from this facility.
Additional Manufacturer Narrative
The sulfur hexafluoride (sf6) gas sample was not returned for testing.A retained sample for lot provided was analyzed by gas chromatograph (gc).The gc analysis confirmed the gas to be sulfur hexafluoride with an air concentration of not more than 100ppm and with no unusual gc peaks, meeting the release specification.There is no evidence contained within the reported information at this time that indicates that the design or performance of the ophthalmic gas contributed to the event reported.The sf6 gas was manufactured on april 23, 2021.A review of the batch production record for lot provided 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 sf6 gas.A review of the complaint records showed no other complaints against lot provided.With no additional, related information provided, the customer reported event could not be confirmed.The root cause of the reported event cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).

• Brand Name: ISPAN SULFUR HEXAFLUORIDE (SF6) GAS
• Common Device Name: INTRAOCULAR GAS
• Manufacturer (Section D): AIR LIQUIDE; 13140 ti blvd.; dallas TX 75243
• MDR Report Key: 11862984
• Report Number: 1610287-2021-00010
• Device Sequence Number: 3193864
• Product Code: LPO
• UDI-Device Identifier: 00380657970056
• UDI-Public: 00380657970056
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P900067
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 8065797005
• Device Lot Number: 011401
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/12/2021
• Supplement Date Received by Manufacturer: 07/27/2021
• Initial Report FDA Received Date: 05/21/2021
• Supplement Report FDA Received Date: 08/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other