MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGACLIP CLIP APPLIER; CLIP, IMPLANTABLE

Catalog Number MCS20

Device Problems Sticking (1597); Activation, Positioning or Separation Problem (2906); Device Operates Differently Than Expected (2913)

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

Event Date 06/08/2015

Event Type  malfunction  

Event Description

It was reported that during an unknown procedure, the doctor was creating a free flap.The sister said that the clips did not deploy properly and the device was stuck on the vessel itself.The doctor could not open the jaws.Another like device was used to complete the procedure.There were no adverse consequences for the patient reported.

Manufacturer Narrative

(b)(4).No device received for analysis at time of submission of 3500a when additional information is received and/or the device analysis has been completed, a supplemental medwatch will be sent.Additional information was requested and the following was obtained: how was the device removed from the vessel.The vessel was clamped on both ends, dissected and the clip applier slipped out of the vessel.After which they used ligaclips to clip of the ends vessel.Was the vessel damaged after the device was removed from the tissue.The vessel was not damaged as they had intended to ligate it.Did the clip feed sideways, or feed slowly into the jaws of the device.The surgeon was not too sure whether there was a clip deployed or not as the jaws of the clip applier could not open.

Manufacturer Narrative

(b)(4).Additional information: the analysis results found that mcs20 was returned in good visual condition.In an attempt to replicate the reported incident, the instrument was functionally tested; upon cycling the handles were noted to be loose and would not close the jaws as intended; no functional testing could be performed due to the returned condition of the instrument.The device was disassembled in order to evaluate the condition of the internal components and the extension spring was observed to be out of position and damaged; this condition contributed that the handles were loose and that the device could not be cycled as intended.No conclusion could be reached as to what may have caused the reported incident.The batch history records were reviewed with no anomalies noted during the manufacturing process.

• Brand Name: LIGACLIP CLIP APPLIER
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo PR 0096 9
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 0096 9
• Manufacturer Contact: milton garrett ; 5133378865
• MDR Report Key: 4885018
• MDR Text Key: 6046834
• Report Number: 3005075853-2015-03978
• Device Sequence Number: 1
• Product Code: GDO
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K820837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/12/2015

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 Expiration Date: 11/02/2019
• Device Catalogue Number: MCS20
• Device Lot Number: L4FG5H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/22/2015
• Initial Date FDA Received: 07/01/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1