MAUDE Adverse Event Report: BAUSCH + LOMB STIFF 25GA TANO DIAMOND DUSTED MEMBRANE SCRAPER (DDMS¿); HANDHELD SURGICAL INSTRUMENT

Model Number	20.04.25S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Eye Injury (1845)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The dhr evaluation did not reveal any negative quality patterns.100% visual inspection of tip for nicks, tears, or cuts, was performed under magnification per inspection form.No ncs associated with the dhr.This investigation is ongoing.
Event or Problem Description
The user facility reported a 25ga tano diamond dusted membrane scrapper (ddms) tip broke off inside patient''s right eye.The surgeon could not remove it through the 25ga cannula.The cannula was removed, the conjunctiva was opened with westcott, and a 20ga sclera incision was made with an micro vitreoretinal (mvr) blade.The tip was removed using internal limiting membrane (ilm) forceps.The incision was closed with 7-0 vicryl suture.Closed conjunctiva with 6-0 plain gut suture.
Additional Manufacturer Narrative
The product evaluation has been completed.Product handle/shaft assembly returned in a original product pouch.Visual inspection confirmed the abrasive silicone bead had broken off approximately.5mm from end of shaft.The base of the silicone bead was still firmly secured inside the shaft tube.The loose piece of the silicone tip of the device was not returned.This potential failure mode is identified and addressed in a 2018 change to our instructions for use document (b)(4) rev m.Warning in ifu states: "only retractable ddms products (20.16, 20.16.23, 20.16.25) are compatible with valved cannula systems.Use of other ddms products (20.04, 20.04.23, 20.04.25s, 20.04.27, 20.07, 20.18) with valved cannula systems may damage flexible tip".In this occurrence it was confirmed a valved cannula was in use at time of the incident.This was a contraindicated action by the user.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.
Additional Manufacturer Narrative
Correction: d4 corrected udi number.

• Brand Name: STIFF 25GA TANO DIAMOND DUSTED MEMBRANE SCRAPER (DDMS¿)
• Common Device Name: HANDHELD SURGICAL INSTRUMENT
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): SYNERGETICS; 3845 corporate centre dr.; o'fallon MO 63368
• Manufacturer Contact: juli moore ; 3365 tree court industrial blvd.; st. louis, MO 63122 ; 6362263220
• MDR Report Key: 18086294
• Report Number: 0001932402-2023-70007
• Device Sequence Number: 6788957
• Product Code: GZX
• UDI-Device Identifier: 20841305108848
• UDI-Public: (01)20841305108848(17)260628(10)M0049344
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/13/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 20.04.25S
• Device Lot Number: M0049344
• 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; 10/04/2024
• Initial Report FDA Received Date: 11/07/2023
• Supplement Report FDA Received Date: 12/08/2023; 10/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown