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 Vascular Dissection (3160)

Event Date 02/13/2018

Event Type  malfunction  

Manufacturer Narrative

The product was not returned to microline surgical, inc.An investigation could not be performed.

Event Description

During a cholecystectomy, the ml-10 clip applier jammed on the cystic duct and could not be opened.The surgeon needed to dissect the channel downstream and cut it off.The procedure and anesthesia time were extended by ten minutes.No additional complications were reported.

Manufacturer Narrative

The device was returned, decontaminated and investigated.The device was returned with a broken bar feeder and with the clip cartridge still stuck inside.Due to the condition of the returned device, a functional test could not be conducted.The handle of the device was then completely taken apart and all the internal components were examined.Results of these evaluation indicate that the reason the device failed was due to a damaged pawl spring.The customer complaint of a jammed clip applier was confirmed.A possible root cause could be an excessive force applied to the device.

Event Description

During a cholecystectomy, the ml-10 clip applier jammed on the cystic duct and could not be opened.The surgeon needed to dissect the channel downstream and cut it off.The procedure and anesthesia time were extended by ten minutes.No additional complications were reported.

• 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
• MDR Report Key: 7337437
• MDR Text Key: 102325261
• Report Number: 1223422-2018-00008
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• PMA/PMN Number: K013695
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 03/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1002
• Device Catalogue Number: 1002
• Device Lot Number: 00109499
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention