MAUDE Adverse Event Report: MICROSURGICAL TECHNOLOGY, INC MST/PACKARD .7MM STRT P TP 30; PHACOEMULSIFICATION TIPS

Model Number	PT-32330-GRN
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Corneal Edema (1791)
Type of Reportable Event	Serious Injury
Event or Problem Description
During october, one surgeon saw an increase in corneal edema.The sleeves do not make it through many cases.We were having issues where irrigation was only coming out of 1 side.The issue was even with new sleeves.Also, the tips bend so easily the baby sitting of them was an issue.While they work great, they are more of a 1 and done.The patients were ok at the first week of the surgery with steroids treating corneal edema.
Additional Manufacturer Narrative
Three unused pn: (b)(6)-grn devices and one unopened sil-0015-grn were returned.Visual inspection did not find anything abnormal.Bhr review shows the devices in the lot were manufactured and passed all inspections per sops.This is the first complaint for lot 186546.

• Brand Name: MST/PACKARD .7MM STRT P TP 30
• Common Device Name: PHACOEMULSIFICATION TIPS
• Manufacturer (Section D): MICROSURGICAL TECHNOLOGY, INC; 8415 154th ave ne; redmond WA 98052
• Manufacturer (Section G): MICROSURGICAL TECHNOLOGY, INC; 8415 154th ave ne; redmond WA 98052
• Manufacturer Contact: sylvia lemke ; 8415 154th ave ne; redmond, WA 98052 ; 4252843772
• MDR Report Key: 20707887
• Report Number: 3019924-2024-00012
• Device Sequence Number: 12775377
• Product Code: HQC
• UDI-Device Identifier: 10844685005434
• UDI-Public: 10844685005434
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K943672
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/15/2024

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 Model Number: PT-32330-GRN
• Device Catalogue Number: PT-32330-GRN
• Device Lot Number: 186546
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2024
• Initial Report FDA Received Date: 11/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown