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

Catalog Number LC310

Device Problem Device Fell (4014)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # unknown.Device analysis: the analysis results confirmed that the lc310 device was returned nonfunctional as the jaws were misaligned; therefore, the clips could not be loaded into the jaws.The certificate records are accessible through external manufacturing, however, no lot or batch were provided, dhr could not be performed.Please note that as stated in the ifu: "all surgical instruments are subject to a degree of wear and tear because of normal use.A regular and precise visual check of the instrument should be made before each use.".

Event Description

It was reported that the clips were falling out of the jaws of the clip applier when the clip was applied to the tissue.No patient involvement was reported.

• Type of Device: APPLIER, SURGICAL, CLIP
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 8612016
• MDR Text Key: 145236534
• Report Number: 3005075853-2019-19144
• Device Sequence Number: 1
• Product Code: GDO
• UDI-Device Identifier: 10705036012665
• UDI-Public: 10705036012665
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 03/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LC310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2019
• Date Manufacturer Received: 04/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1