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

Catalog Number MCL20

Device Problem Component Falling (1105)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/23/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We did not receive a batch or lot number for the product involved in this complaint.Therefore, we were unable to check manufacturing records for any related non-conformance.If further details are received at a later date a supplemental medwatch will be sent.You have stated that the clips were "falling off".Did clips fall off of the jaws of the device without being fired? did clips fall off of the tissue or vessel they were applied to? when the device clips "miss-loaded" were the clips not fed into the jaws? did the clips feed sideways into the jaws?.

Event Description

It was reported that during a colon resection procedure, the surgeon having issues with clips scissoring, falling off, and miss loading.Another like device was used to complete the procedure.There were no adverse consequences for the patient.

• Brand Name: LIGACLIP MCA LARGE 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: 6697256
• MDR Text Key: 79905927
• Report Number: 3005075853-2017-03412
• Device Sequence Number: 1
• Product Code: GDO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K820837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MCL20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1