MAUDE Adverse Event Report: BAUSCH + LOMB 25GA COMB PK W V&AFI&WF; UNIT, PHACOFRAGMENTATION

Model Number	BL5525WV
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One opened bl5525wv pack from lot v8993 was returned.The tip protector was not returned.Visual examination found that the needle is bent, the port window is in the opened position and dried solution is visible in the tubing.The back cap is aligned correctly with the vent hole in the side of the cutter body.The connectors were inspected and no defects were found.A functional test was performed using a stellaris pc system.The cutter did not cut.The inner needle is binding up and blocking the port window, preventing cutting and aspiration.It should be noted that a bent needle could contribute to poor cutting performance.The cause of the bent needle cannot be determined.
Event or Problem Description
A report received from a user facility in the (b)(4) stated that during the procedure, the vitrectomy cutter was not cutting well and needed to be replaced.There was no report of injury or consequences to the patient.

• Brand Name: 25GA COMB PK W V&AFI&WF
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 6777353
• Report Number: 0001920664-2017-00260
• Device Sequence Number: 16433548
• Product Code: HQC
• UDI-Device Identifier: 00757770058631
• UDI-Public: (01)00757770058631(17)180904
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K101325
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/12/2017

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: 09/04/2018
• Device Model Number: BL5525WV
• Device Catalogue Number: BL5525WV
• Device Lot Number: V8993
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2017
• Initial Report FDA Received Date: 08/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1