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

Catalog Number LC310

Device Problems Corroded (1131); Failure to Align (2522); Failure to Form Staple (2579)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date of event: unknown.Batch # unknown.The batch was not provided; therefore, the manufacturing records could not be reviewed.

Event Description

It was reported that the clip applier presented with oxidized rings and bad clip formation due to the misaligned jaws.

• 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: 8696639
• MDR Text Key: 148028591
• Report Number: 3005075853-2019-19697
• Device Sequence Number: 1
• Product Code: GDO
• UDI-Device Identifier: 10705036012665
• UDI-Public: 10705036012665
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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
• Report Date: 05/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: LC310
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1