MAUDE Adverse Event Report: SURGICAL SPECIALTIES CORPORATION SHARPOINT; :2DSL6 10-0 BKMONO NYL 12"/30CM

Model Number	A7770N
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The actual device not available for review, sterile devices from the same lot not available for testing/review.No retains available for review.No photos of the incision were provided.A review of the device history records confirmed there were no quality issues noted throughout the incoming inspection of raw material suture, manufacturing of the finished good, in-process or final inspection process.Sutures are time-consuming to place, can induce astigmatism, may require removal and often cause conjunctival hemorrhage.Additionally, they can be a nidus for infection, inflammation and neovascularization.Wounds closed with sutures also have been known to leak.Without receiving details regarding the procedure performed, placement of the suture, the surgeon's technique or photos of the leaking wound, receiving sutures from the same lot to review/test, a definitive root cause cannot be determined at this time.
Event or Problem Description
The patient was hospitalized after being diagnosed with cataract and glaucoma within both eyes.On (b)(6) 2020, combined surgery of glaucoma and cataract were performed on the patient.Liquid leakage was detected after suturing and another suturing process was immediately performed.No leakage was detected after the second suturing process.

• Brand Name: SHARPOINT
• Common Device Name: :2DSL6 10-0 BKMONO NYL 12"/30CM
• Manufacturer (Section D): SURGICAL SPECIALTIES CORPORATION; corredor tijuana rosarito 2000; #24702-b ejido francisco villa; tijuana 22235 ; MX 22235
• MDR Report Key: 11638985
• Report Number: 3010692967-2021-00012
• Device Sequence Number: 16919065
• Product Code: GAB
• UDI-Device Identifier: 10848782010735
• UDI-Public: (01)10848782010735(17)220831(10)AABQ757
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• PMA/510(K) Number: K903029
• Number of Events Summarized: 123
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/08/2021
• Report Date (Section F): 03/25/2021

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: 08/17/2022
• Device Model Number: A7770N
• Device Lot Number: AABQ757
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/26/2020
• Device Age: 44 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/25/2021
• Type of Report(Section G): Fifteen-Day
• Initial Date Received by Manufacturer: 03/25/2021
• Initial Report FDA Received Date: 04/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71