MAUDE Adverse Event Report: NEW WORLD MEDICAL, INC. STREAMLINE SURGICAL SYSTEM; INFUSION PUMP

Model Number	10-0066
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	04/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history record for the reported lot was reviewed and no issues were observed.Product from this lot was manufactured, tested, and released per validated procedures.Communication with the device user indicated that the device tip may have inadvertently touched the affected tissue when performing the procedure.Per the device ifu, descemet's membrane tear is a potential adverse event from usage of the device.The ifu warns, "to avoid touching the corneal endothelium and iris with streamline" as well as cautioning for adequate physician training.Nwm representatives provide approved training options to physicians.The cause of this event could be attributed to unintended user error.
Event or Problem Description
Nwm surgical sales consultant reported "potential descemet tear after perform streamline click pulse applications.".

• Brand Name: STREAMLINE SURGICAL SYSTEM
• Common Device Name: INFUSION PUMP
• Manufacturer (Section D): NEW WORLD MEDICAL, INC.; 10763 edison court; rancho cucamonga CA 91730
• Manufacturer (Section G): NEW WORLD MEDICAL, INC.; 10763 edison court; rancho cucamonga CA 91730
• Manufacturer Contact: cristina avalos ; 10763 edison court; rancho cucamonga, CA 91730 ; 9098705446
• MDR Report Key: 16856447
• Report Number: 1000125279-2023-00016
• Device Sequence Number: 7648353
• Product Code: MRH
• UDI-Device Identifier: 00892064002010
• UDI-Public: (01)00892064002010(11)220610(17)230610(10)F1822
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K211680
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/02/2023

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 Expiration Date: 06/10/2023
• Device Model Number: 10-0066
• Device Catalogue Number: 10-0066
• Device Lot Number: F1822
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2023
• Initial Report FDA Received Date: 05/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown