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U.S. Department of Health and Human Services

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

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SURGICAL SPECIALTIES CORPORATION SHARPOINT :2DSL6 10-0 BKMONO NYL 12"/30CM Back to Search Results
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.
 
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Brand NameSHARPOINT
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 Key11638985
MDR Text Key244613248
Report Number3010692967-2021-00012
Device Sequence Number1
Product Code GAB
Combination Product (y/n)Y
Reporter Country CodeCH
PMA/PMN Number
K903029
Number of Events Reported123
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 Received04/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberA7770N
Device Lot NumberAABQ757
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Distributor Facility Aware Date10/26/2020
Device Age44 MO
Event Location Hospital
Date Report to Manufacturer03/25/2021
Date Manufacturer Received03/25/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/17/2017
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
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