MAUDE Adverse Event Report: MILLENNIUM SURGICAL 8 MM , 33 CM SILASTIC RING APPLICATOR; DEVICE, OCCLUSION, TUBAL, CONTRACEPTIVE

Model Number 52208-500

Device Problem Failure to Fire (2610)

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

Event Date 09/21/2020

Event Type  malfunction  

Event Description

Four fallopian applicators failed during surgery.The first applier did not fire; the second applier was missing the bottom ring; the third applier did not fire; and the fourth applier fired once.

• Brand Name: 8 MM , 33 CM SILASTIC RING APPLICATOR
• Type of Device: DEVICE, OCCLUSION, TUBAL, CONTRACEPTIVE
• Manufacturer (Section D): MILLENNIUM SURGICAL; 3002 ave. antonio r barcelo; suite 25; cayey PR 00737
• MDR Report Key: 10689595
• MDR Text Key: 211667099
• Report Number: 10689595
• Device Sequence Number: 1
• Product Code: KNH
• 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: 10/06/2020

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 Operator: Health Professional
• Device Model Number: 52208-500
• Device Catalogue Number: 52208-500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/06/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/16/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 12045 DA