MAUDE Adverse Event Report: GYRUS ACMI, INC. DISPOSABLE FALOPE RING BAND APP KIT WITH 8MM DISPOSABLE TROCAR; DEVICE, OCCLUSION, TUBAL, CONTRACEPTIVE

Model Number 005280-901

Device Problem Mechanics Altered (2984)

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

Event Date 05/17/2022

Event Type  malfunction  

Event Description

The spring mechanism in the trocar was broken and did not allow the provider to apply the band to the fallopian tube.

• Brand Name: DISPOSABLE FALOPE RING BAND APP KIT WITH 8MM DISPOSABLE TROCAR
• Type of Device: DEVICE, OCCLUSION, TUBAL, CONTRACEPTIVE
• Manufacturer (Section D): GYRUS ACMI, INC.; 800 west park drive; westborough MA 01581
• MDR Report Key: 14773211
• MDR Text Key: 294504364
• Report Number: 14773211
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/09/2022

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: 005280-901
• Device Lot Number: KR115534
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/09/2022
• Event Location: Hospital
• Date Report to Manufacturer: 06/22/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/22/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1