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

Model Number 005280-901

Device Problem Failure to Discharge (1169)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/19/2020

Event Type  malfunction  

Manufacturer Narrative

The subject device has not yet been received for evaluation.The cause of the issue cannot be determined at this time.If additional information becomes available this report will be supplemented accordingly.

Event Description

It was reported that during a bilateral tubal ligation (btl), the falope ring failed to deploy.The user fulgurated the tubes to complete the intended procedure.According to the user, there was a delay on the case however, no patient harm or injury was reported.The patient according to the reporter was stable.

Manufacturer Narrative

This supplemental report is being submitted to provide the device history record and device evaluation.Device was evaluated with confirmed serial number (b)(6).Evaluation determined that the returned applicator found no physical abnormalities.The device was found intact and in good condition.The firing position of the device could be selected as designed, tongs were extended and was retracted smoothly.There was no damaged found on the tongs.A rubber band was used as a simulated fallopian tube and the device was tested per ifu instructions.The device properly deployed both ring bands.The functional testing was repeated two additional times.A total of 6 bands deployed successfully.The user's report could not be replicated.The dhrs for this product have been reviewed.All records indicate that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.There are no associated ncrs, reported scrap or recorded process deviations relating to the reported failure.Based on device evaluation, the reported issue was not duplicated.The device performed as expected with no issues observed.The root cause of the reported failure could not be determined.

Manufacturer Narrative

This supplemental report is being submitted to provide the device unique device identifier (udi) number.

Manufacturer Narrative

This supplemental report is being submitted to inform that upon further review this is not a reportable malfunction.Per the legal manufacturer there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.Please see updated sections: g4, g7, h2 and h10.

• Brand Name: FBK DUAL INC. W/TROCAR 8/PK
• Type of Device: CONTRACEPTIVE, TUBAL OCCLUSION CLIP/BAND
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 9992681
• MDR Text Key: 209360627
• Report Number: 2951238-2020-00429
• 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: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/16/2021

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: 005280-901
• Device Lot Number: KR866973
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/26/2020
• Initial Date FDA Received: 04/23/2020
• Supplement Dates Manufacturer Received: 05/07/2020; 01/20/2021; 02/10/2021
• Supplement Dates FDA Received: 06/01/2020; 01/22/2021; 02/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 35 YR