MAUDE Adverse Event Report: BAUSCH + LOMB POSTERIOR VITRECTOMY PACK; UNIT, PHACOFRAGMENTATION

Model Number	BL5323W
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
The product has been requested for evaluation however it has not yet been received.
Event or Problem Description
The cutter stops cutting after 10 minutes, a new cutter is required to finish the surgery.No patient impact or injury reported.
Additional Manufacturer Narrative
Two 23 gauge vitrectomy cutters were returned wadded up in a plastic bag along with a bl5323wv pack label from lot v8647.The part number and lot number could not be verified or determined for the cutter returned without a pack label.The tip protectors were not returned.The needles were bent.The port windows were in the opened position.There was dried solution visible in the tubing.The back caps were aligned correctly with the vent holes in the side of the cutter body.The connectors were inspected and no defects were found.Functional testing was performed using a stellaris pc system.The cutters did not cut.The inner needle was binding up and does not reach the cutting edge.A bent needle could contribute to poor cutting performance.The cause of the bent needles cannot be determined.

• Brand Name: POSTERIOR VITRECTOMY PACK
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 6759603
• Report Number: 0001920664-2017-00259
• Device Sequence Number: 11148046
• Product Code: HQC
• UDI-Device Identifier: 00757770058563
• UDI-Public: (01)00757770058563(17)180630
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 07/03/2017

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: Health Professional
• Device Expiration Date: 06/30/2018
• Device Model Number: BL5323W
• Device Catalogue Number: BL5323WV
• Device Lot Number: V8647
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2017
• Initial Date Received by Manufacturer: 07/03/2017
• Supplement Date Received by Manufacturer: 09/13/2017
• Initial Report FDA Received Date: 08/02/2017
• Supplement Report FDA Received Date: 09/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1