MAUDE Adverse Event Report: GYRUS ACMI, INC FBK DUAL INC. W/O TROCAR 8/PK; LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Model Number 006889-901

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/23/2020

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned for evaluation.If additional information becomes available following device evaluation, a supplemental report will be filed.

Event Description

The user facility reported that the device malfunctioned during a procedure.The physician's report stated that the clip did not release when needed.The procedure was completed using another device of the same model.No patient harm was reported.No additional information has been obtained.

Manufacturer Narrative

The device was returned to olympus for inspection.During the evaluation the lot number was confirmed.The loading pin was pulled and the device was set between firing position one and two.No physical abnormalities were noted during physical inspection, the device is intact and in good condition.The device was reset to firing position one, a loading pin was inserted and two falope ring bands were loaded per instructions for use (ifu).The device deployed both ring bands as designed.No additional information was obtained.A device history record (dhr) did not find any defects or nonconformities.All records indicate that the device was manufactured in accordance with all applicable procedures.Evaluation of the returned device was unable to confirm the complaint.The device functioned as intended.The device was returned with the selector switch between firing position one and two.Firing the device in this state would prevent the second falope ring band from firing properly likely resulting in the reported phenomenon.It is crucial the selector switch is properly set prior to use.The device ifu (man-8115 rev jd) states "when selecting a firing position, rotate the index lever until a positive stop is felt.To set the first firing position, line up the index lever with the single arrow marking on the handle (1).This will limit operating slide allowing only one falope-ring band to be released during firing.Caution: the index lever must be on single arrow position to fire one band.If the index lever is between arrows, both bands may be fired.".

• Brand Name: FBK DUAL INC. W/O TROCAR 8/PK
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 10314996
• MDR Text Key: 219547373
• Report Number: 3011050570-2020-00024
• Device Sequence Number: 1
• Product Code: KNH
• Combination Product (y/n): N
• PMA/PMN Number: P870076
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Type of Report: Initial,Followup
• Report Date: 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 006889-901
• Device Lot Number: KR888125
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1