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

Model Number	BL5625
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One opened pouch was received.The tip protector was not returned.The needle is bent.The port window is in the opened position with no visible debris.There was fluid 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 cutter had good clean cuts throughout the various cut rates and had good aspiration.Sterilization and lot history records were reviewed and no exceptions were found.
Event or Problem Description
The vitreous was caught on the front of the cutter.No patient impact.Additional information regarding the nature of the problem has been requested.
Additional Manufacturer Narrative
Additional information received states the cutter is not cutting so the vitreous gets caught between the cutter hole.They changed the cutter and continued the surgery.

• Brand Name: 25 GA HIGH SPEED VITRECTOMY CUTTER
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 7396638
• Report Number: 0001920664-2018-00043
• Device Sequence Number: 723737
• Product Code: HQC
• UDI-Device Identifier: 20757770057928
• UDI-Public: (01)20757770057928(17)190114
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2018

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: Health Professional
• Device Expiration Date: 01/14/2019
• Device Model Number: BL5625
• Device Lot Number: V9874
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2018
• Initial Date Received by Manufacturer: 03/05/2018
• Supplement Date Received by Manufacturer: 03/25/2018
• Initial Report FDA Received Date: 04/04/2018
• Supplement Report FDA Received Date: 05/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1