MAUDE Adverse Event Report: MICROLINE SURGICAL INC. ML-10 MUTI-FIRE CLIP APPLIER; CLIP IMPLANTABLE

Model Number 1002

Device Problem Mechanical Jam (2983)

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

Event Date 09/24/2017

Event Type  malfunction  

Manufacturer Narrative

Product not returned.No investigation can be performed at this time.

Event Description

During a surgical cholecystectomy, the surgeon attempted to fire a clips and experienced a mechanical jam.The procedure and anesthesia time was extended for 20 minutes.There was no harm to the patient.

Manufacturer Narrative

The device was returned, decontaminated and visually investigated.There were signs of physical damages on the device.The device was returned with a broken bar feeder and with a clip cartridge still stuck in the chamber.These are both indicators that the device did indeed experience a mechanical jam.To determine why the device would not operate as intended, the hand-piece was opened and all internal components were examined.The clip feed mechanism was unresponsive and would not move.The feeder bar was cut and the clip push mechanism moved freely allowing for the clip cartridge to be removed from the device.Upon removal of the clip cartridge 6 open clips fell out of the device along with 1 crimped pin.This is a clear indication that the device was fired incorrectly, possible in the upward direction, with the jaws of the device pointing up.If the device is fired this way, the clip will fall back into the device, so that when the next clip is fired the device will experience a mechanical jam.This complaint is confirmed.A possible root cause may have been due you the device being activated in the wrong position.Ref: 1223422-2017-00132, 1223422-2017-00133, 1223422-2017-00134, 1223422-2017-00135.

• Brand Name: ML-10 MUTI-FIRE CLIP APPLIER
• Type of Device: CLIP IMPLANTABLE
• Manufacturer (Section D): MICROLINE SURGICAL INC.; 50 dunham road; suite 1500; beverly MA 01915
• Manufacturer (Section G): MICROLINE SURGICAL, INC.; 50 dunham road; suite 1500; beverly MA 01915
• Manufacturer Contact: anu gaur ; 50 dunham road; suite 1500; beverly, MA 01915 ; 9789229810
• MDR Report Key: 7013618
• MDR Text Key: 92649084
• Report Number: 1223422-2017-00132
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: K013695
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/20/2017

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: 1002
• Device Catalogue Number: 1002
• Device Lot Number: 00133658
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/13/2017
• Initial Date FDA Received: 11/09/2017
• Supplement Dates Manufacturer Received: 10/13/2017
• Supplement Dates FDA Received: 12/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1