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

Model Number A7770N

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/26/2020

Event Type  Injury  

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 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
• Type of Device: :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
• Manufacturer Contact: luis knappenberger ; 1100 berkshire blvd.; ste 308; reading, PA 19608
• MDR Report Key: 11638985
• MDR Text Key: 244613248
• Report Number: 3010692967-2021-00012
• Device Sequence Number: 1
• Product Code: GAB
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: K903029
• Number of Events Reported: 123
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/25/2021,04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: A7770N
• Device Lot Number: AABQ757
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

• 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
• Date Manufacturer Received: 03/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 04/08/2021 Patient Sequence Number: 1