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

Model Number	BL5525WV
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
Product has been requested for evaluation however it has not been received.Sterilization and lot history records were reviewed and no exceptions were found.
Event or Problem Description
The vitreous was caught in 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.One 25 gauge vitrectomy cutter was received in a plastic bag along with the bl5525wv pack label from lot v9127.The tip protector was not returned.The needle was bent.The port window was in the opened position with debris visible inside.There was dried solution visible in the tubing.The back cap was aligned correctly with the vent hole on 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.The cutter cuts and aspirates as intended.Due to the returned condition, loose in a bag with no tip protector, the cause of the bent needle cannot be determined.The reported problem was not duplicated.

• Brand Name: POSTERIOR VACUUM PACK
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 7396668
• Report Number: 0001920664-2018-00044
• Device Sequence Number: 18841518
• Product Code: HQC
• UDI-Device Identifier: 00757770058631
• UDI-Public: (01)00757770058631(17)180925
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,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: 09/25/2018
• Device Model Number: BL5525WV
• Device Catalogue Number: BL5525WV
• Device Lot Number: V9127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2018
• Initial Date Received by Manufacturer: 03/05/2018
• Supplement Date Received by Manufacturer: 03/05/2018
• 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