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

Catalog Number MCM30

Device Problems Defective Device (2588); Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/24/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).When additional information is received and/or the device analysis has been completed, a supplemental medwatch will be sent.Batch # unk.The lot history records were reviewed and the manufacturing criteria were met prior to the release of this lot.

Event Description

It was reported that during an unknown procedure, the device is defective, it does not re-open.Another like device was used to complete the procedure.There were no adverse consequences for the patient.

Manufacturer Narrative

(b)(4).Batch # m92a60.The analysis results found that the mcm30 device was returned in good visual condition.In an attempt to replicate the reported incident, the device was tested for functionality.Upon testing, the device was cycled and it fed and formed the remaining 22 clips as intended.As the device was found to be fully functional, it could not be determined 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 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 00969
• Manufacturer Contact: milton garrett ; 4545 creek road ml 120a; cincinnati, OH 45242 ; 5133378865
• MDR Report Key: 5366786
• MDR Text Key: 35987691
• Report Number: 3005075853-2016-00280
• Device Sequence Number: 1
• Product Code: GDO
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K820837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/13/2016

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: 07/14/2020
• Device Catalogue Number: MCM30
• Device Lot Number: M4HY9W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/22/2015
• Initial Date FDA Received: 01/14/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1