MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDOSUTURE SUTURE ASSISTANT; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Catalog Number SW100

Device Problem Material Integrity Problem (2978)

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

Event Type  malfunction  

Event Description

It was reported that during a nissen fundoplication procedure; the knot ripped apart.The procedure was completed using same like device.There were no adverse consequences for the patient reported.

Manufacturer Narrative

(b)(4).Information asked for but unknown or not provided during initial contact.Information not available, device not returned for analysis should the information be provided later, a supplemental medwatch will be sent.

• Brand Name: ENDOSUTURE SUTURE ASSISTANT
• Type of Device: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• 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 0096 9
• Manufacturer Contact: milton garrett ; 5133378865
• MDR Report Key: 4883325
• MDR Text Key: 15912480
• Report Number: 3005075853-2015-03952
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K972679
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/18/2015

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 Catalogue Number: SW100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/18/2015
• Initial Date FDA Received: 07/01/2015
• 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