MAUDE Adverse Event Report: BAUSCH + LOMB ONE-STEP SUTURELESS CANNULA; HANDHELD SURGICAL INSTRUMENT

Model Number	58.20
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product has been requested.Manufacturing records were reviewed and found to be acceptable.The lot history, trend analysis, risk analysis and directions for use review were considered acceptable, with the product performing within anticipated rates.The investigation is ongoing.
Event or Problem Description
It was reported by the user facility that the canula broke out of the trocar and was in tissue of the right eye.The doctor had to remove the product from the tissue with forceps and one vicryl was needed.
Additional Manufacturer Narrative
The cannula was returned in two pieces.A portion of the polyimide tube is still bonded to the hub with approximately.040" protruding.A separated part of the tubing was loose in the bottle.Visual inspection under magnification shows the point of separation of the polyimide tubing was reduced in diameter, had soft curled edges, and a stretched strand of plastic bridging the opening of the loose half.Evidence is indicative of the material melting.User confirmed that the device was used in a 20g fragmentation instrument.This was a contraindicated action by the user.The sample was sent to the vendor, and their evaluation of the cannula could not determine a cause of the break.Their device history records confirmed all materials used were as specified, and assemblies were inspected and packaged by trained personnel.They could not determine a root cause.No corrective action is required.

• Brand Name: ONE-STEP SUTURELESS CANNULA
• Common Device Name: HANDHELD SURGICAL INSTRUMENT
• Manufacturer (Section D): BAUSCH + LOMB; 1400 n goodman st; rochester NY 14609
• Manufacturer (Section G): SYNERGETICS USA, INC; 3845 corporate centre drive; o'fallon MO 63368
• Manufacturer Contact: juli moore ; 3365 tree court industrial blvd; st. louis, MO 63122 ; 6362263220
• MDR Report Key: 20138421
• Report Number: 0001920664-2024-00102
• Device Sequence Number: 7305367
• Product Code: MDM
• UDI-Device Identifier: 20841305108152
• UDI-Public: (01)20841305108152(17)260201(10)M0046857
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• 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): 08/13/2024

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?: Yes
• Device Model Number: 58.20
• Device Lot Number: M0046857
• 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: 08/13/2024
• Supplement Date Received by Manufacturer: 09/27/2024
• Initial Report FDA Received Date: 09/04/2024
• Supplement Report FDA Received Date: 10/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Sex: Unknown