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

Catalog Number	8065797002
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 health professional reported that an ophthalmic gas bubble did not expand while inside of the patient¿s right eye for over 1-2 weeks rather, the bubble just dissipated over a few days with no expansion.There was no harm to the patient.
Additional Manufacturer Narrative
Per the contract manufacturer evaluation, a check of the batch production record for the reported lot number was performed.Which confirmed, that the product met specifications at the time of release.Additionally, a check of the complaint records showed, no other complaints against the reported lot.The reported ophthalmic gas was unable to be evaluated, because a sample was not returned.As no sample was returned for evaluation.And with no additional, related information provided, the customer reported event was not confirmed.Based on the information obtained, the root cause of the reported event cannot be determined conclusively.The root cause of the reported event could not be determined.Therefore, no further actions can be pursued at this time.Quality assurance has reviewed this complaint.And will continue to monitor data for evidence of adverse trend and take further action, as appropriate.At a minimum, this will include completing reviews of complaint class report levels on a monthly basis by the product team.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: 12263768
• Report Number: 1610287-2021-00017
• Device Sequence Number: 14361331
• Product Code: LPO
• UDI-Device Identifier: 00380657970025
• UDI-Public: 00380657970025
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2021

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: 8065797002
• Device Lot Number: 905911
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/08/2021
• Supplement Date Received by Manufacturer: 10/04/2021
• Initial Report FDA Received Date: 08/02/2021
• Supplement Report FDA Received Date: 10/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ISPAN GAS TANK REGULATOR; REGULATOR-NEW DESIGN,
• Patient Age: 61 YR