MAUDE Adverse Event Report: SURGICAL SPECIALTIES CORPORATION SHARPOINT; 15 DEGREE MICROKNIFE

Model Number	72-1501
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	05/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history records for the reported finished good lot and raw material components was performed and no quality issues were identified.The blades were verified to be in the handles, passed alignment inspection, and passed the pull test.The blade/knife were not returned from the end user for review.Magnified photos of the device have not been received for review.No adverse event was reported at this time.Complaints will continue to be monitored.Appropriate materials were selected to meet the design requirements.No further control measures are deemed necessary at this time.
Event or Problem Description
It was reported that the blade was turning during the surgical procedure.A knife was used to make an auxiliary incision with an ophthalmic scalpel and it was found that the blade of the knife was turned over, which resulted in unevenness of the incision and damage to the corneal endothelium after puncture.Intervention was made during the surgical procedure to reduce the infection caused by poor incision closure and completed the surgical procedure.The patient was treated with an operation called "ultrasonic emulsification removal of cataract and iol implantation in the right eye" under local anesthesia.

• Brand Name: SHARPOINT
• Common Device Name: 15 DEGREE MICROKNIFE
• Manufacturer (Section D): SURGICAL SPECIALTIES CORPORATION; corredor tijuana rosarito 2000; #24702 b; tijuana baja california 22235
• Manufacturer (Section G): SURGICAL SPECIALTIES CORPORATION; 247 station drive; westwood
• Manufacturer Contact: virnalisa cobacha ; corredor tijuana-rosarito 2000 #24702b; ejido francisco villa; tijuana
• MDR Report Key: 19629618
• Report Number: 3010692967-2024-00039
• Device Sequence Number: 20617344
• Product Code: HNN
• UDI-Device Identifier: 00848782027293
• UDI-Public: (01)00848782027293(17)270527(10)C622LCL
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/05/2024
• Report Date (Section F): 05/23/2024

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
• Operator of Device: Health Professional
• Device Model Number: 72-1501
• Device Lot Number: C622LCL
• Was the Report Sent to FDA?: No
• Device Age: 1 YR
• Date Report to Manufacturer: 05/23/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2024
• Initial Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/28/2022
• 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