MAUDE Adverse Event Report: SURGICAL SPECIALTIES MÉXICO, S. DE R.L. DE C.V. 2HGL5 10-0 BKMONO NYL 12/30CM; SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE

Model Number A9000N

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/22/2022

Event Type  malfunction  

Event Description

During complex cataract extraction right eye surgery, md attempted to use the suture needle and noted that the top needle popped off the thread before he used on the patient.The md attempted to locate the needled and it was not found.He verified needle was not in the surgical field.No patient harm.No device available to return, unable to identify lot number.

• Brand Name: 2HGL5 10-0 BKMONO NYL 12/30CM
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE
• Manufacturer (Section D): SURGICAL SPECIALTIES MÉXICO, S. DE R.L. DE C.V.; 247 station drive ne1; westwood MA 02090
• MDR Report Key: 14546900
• MDR Text Key: 292995794
• Report Number: 14546900
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: A9000N
• Device Catalogue Number: A9000
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/11/2022
• Date Report to Manufacturer: 05/31/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/31/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25185 DA