MAUDE Adverse Event Report: BAUSCH + LOMB 25GA FLEXIBLE TAPERED ILLUMINATED LASER PROBE; OPHTHALMIC LASER SYSTEM BEAM GUIDE

Model Number	55.70.25P
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This investigation is ongoing.
Event or Problem Description
The sales rep on site for surgery reported the laser probe got stuck in the trocar cannula during laser retinopexy.The laser probe was too thick to go through cannula.The doctor ended up having to suture the sclerotomy with a vicryl 7.0 suture.
Additional Manufacturer Narrative
One used 55.70.25p, 25ga flexible tapered illuminated laser probe from lot m0045478 was received for evaluation.The sample was received in an open pouch without any needle cover or protective clamshell.The probe was removed and examined.The probe had surgical residue on it.The nitinol tubing was found to have been pinched/broken near the needle cutoff juncture.The laser light path and illumination light paths were both still intact.Measurements were made on the cutoff tube od using a calibrated micrometer.The tube od measured.0202¿, which is in tolerance for a 25ga tube (.0200¿ to.0205¿).The nitinol tubing was measured and found to be in tolerance per the drawing (.0160 +/-.0005).The nitinol od measured.01615¿.At the wider area of the pinch / break the nitinol measured ~.01855¿ due to the pinched condition of the tubing.The probe was then pushed through a 25ga alcon valved cannula port 6mm.The entry was not as smooth as it should have been (due to the pinched nitinol).Removal of the nitinol from the port did indeed pull out the cannula port.The movement of the probe in and around the cannula would definitely have been exacerbated by the pinched/broken nitinol.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action required.The investigation is complete.

• Brand Name: 25GA FLEXIBLE TAPERED ILLUMINATED LASER PROBE
• Common Device Name: OPHTHALMIC LASER SYSTEM BEAM GUIDE
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB, INC.; 3365 tree court industrial blv; st. louis MO 63122
• Manufacturer Contact: juli moore ; 3845 corporate centre dr.; o''fallon, MO 63368 ; 6362263220
• MDR Report Key: 18152268
• Report Number: 0001932402-2023-70008
• Device Sequence Number: 20480027
• Product Code: HQB
• UDI-Device Identifier: 20841305107094
• UDI-Public: (01)20841305107094(17)251018
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K954306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/18/2025
• Device Model Number: 55.70.25P
• Device Lot Number: M0045478
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/16/2023
• Supplement Report FDA Received Date: 01/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALCON 25GA VALVED CANNULA
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown