MAUDE Adverse Event Report: BAUSCH + LOMB 23 GA POSTERIOR PORCEDUAL PACK WITH INTEGRATED VENTED AFI&WF; UNIT, PHACOFRAGMENTATION

Model Number	BL5423WV
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation completed.One opened bl5423wv vitrectomy cutter from lot w0965 was returned in a plastic bag.The expiration date on the label was 2019-06-16.The tip protector was not returned.The needle was bent.The port window was in the opened position.There was fluid in the aspiration line.The back cap was aligned correctly with the vent hole in the side of the cutter body.The connectors were inspected and no damage was found.A functional test was performed using a stellaris pc system.The cutter had good clean cuts and good aspiration.This cutter performed as intended.The cause of the reported problem could not be determined.The sterilization and lot history records were reviewed and found to be acceptable.
Event or Problem Description
The cutter would not cut.There was patient contact but no injury.The doctor opened a new cutter and the surgery was completed with no issues.

• Brand Name: 23 GA POSTERIOR PORCEDUAL PACK WITH INTEGRATED VENTED AFI&WF
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 7426567
• Report Number: 0001920664-2018-00048
• Device Sequence Number: 13761516
• Product Code: HQC
• UDI-Device Identifier: 00757770058556
• UDI-Public: (01)00757770058556(17)190616
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K101325
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 03/19/2018

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: Physician
• Device Expiration Date: 06/16/2019
• Device Model Number: BL5423WV
• Device Catalogue Number: BL5423WV
• Device Lot Number: W0965
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2018
• Initial Report FDA Received Date: 04/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1