MAUDE Adverse Event Report: BAUSCH + LOMB 25 GA HIGH SPEED VITRECTOMY CUTTER; UNIT, PACOFRAGMENTATION

Model Number	BL5625
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sterilization and lot history records were reviewed and found to be acceptable.
Event or Problem Description
The user facility in (b)(6) reported a vitrectomy cutter did not move properly.It did aspirate, but did not cut.It was replaced with another cutter and surgery was completed.No patient injury reported.
Additional Manufacturer Narrative
Evaluation completed.One opened bl5625 pouch from lot v9180 was returned.The expiration date on the label was 2018-10-01.The tip protector was not returned.The needle was bent.The port window was in the opened position.There was dried solution visible in the tubing.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 assembly had good clean cuts and aspirated as intended.The cause of the bent needle cannot be determined, due to evidence of use.

• Brand Name: 25 GA HIGH SPEED VITRECTOMY CUTTER
• Common Device Name: UNIT, PACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 7121548
• Report Number: 0001920664-2017-00308
• Device Sequence Number: 1358766
• Product Code: HQC
• UDI-Device Identifier: 20757770057928
• UDI-Public: (01)20757770057928(17)181001
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K101325
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2017

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: 10/01/2018
• Device Model Number: BL5625
• Device Lot Number: V9180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2018
• Initial Date Received by Manufacturer: 11/29/2017
• Supplement Date Received by Manufacturer: 02/12/2018
• Initial Report FDA Received Date: 12/15/2017
• Supplement Report FDA Received Date: 03/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1