MAUDE Adverse Event Report: BAUSCH + LOMB 25G BI-B POSTERIOR ELITE W WF; UNIT PHACOFRAGMENTATION

Model Number SE5425WVB

Device Problem Failure to Cut (2587)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/29/2021

Event Type  malfunction  

Manufacturer Narrative

The sterilization and lot history records were reviewed and found to be acceptable.

Event Description

The user facility reported the cutter would not work or cut.There was patient contact, but no patient injury.A new pack of same lot was opened and used without issue to finish the case.

Manufacturer Narrative

The evaluation has been completed.One opened se5425wvb pack from lot w8137 was returned.The expiration date on the label was 2022-mar-29.Visual inspection found the vitrectomy cutter tip protector was not returned.The cutter was loose in the pack tray.There was dried solution visible in the tubing.The needle tip was broken off at the base.The broken piece of the needle was not received.Microscopic examination found that the cannula shape was oval but should be round.This indicates a flattening out of the cannula, which could happen during bending.One side of the broken area has evidence of stretching and the opposite side has compression stress marks.The evidence suggests that this tip was bent at some point, which could contribute to the breaking of the cannula.Due to evidence of use and the returned condition, loose in the pack tray with no tip protector, the cause of the broken cannula could not be determined.Root cause is unknown/inconclusive due to the damaged condition in which the part was returned (missing the needle) it is not possible to determine a cause for the reported complaint.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.This investigation is complete.

• Brand Name: 25G BI-B POSTERIOR ELITE W WF
• Type of Device: UNIT PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 11351827
• MDR Text Key: 249129465
• Report Number: 0001920664-2021-00016
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): Y
• PMA/PMN Number: K170052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 02/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/29/2022
• Device Model Number: SE5425WVB
• Device Catalogue Number: SE5425WVB
• Device Lot Number: 222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1