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

Catalog Number SW110

Device Problem Component Falling (1105)

Patient Problem Foreign body, removal of (2365)

Event Date 02/09/2015

Event Type  malfunction  

Event Description

It was reported that during a laparoscopic gastric sleeve procedure, upon deploying the knot, three little pieces fell off of the suture cartridge.All pieces were retrieved from the patient and saved for analysis.Case completed with another device of the same product code.

Manufacturer Narrative

(b)(4).Should the information be provided later, a supplemental medwatch will be sent.The analysis results found that a sw110 device was returned disassembled; the valve tube, the cartridge base and the cartridge plate were returned separated.Each component was inspected and physical evidence associated with user error was found as scratches were noted to be on both sides of the cartridge plate and it was observed to be slightly bent; the damages found on the cartridge base were scratches on one of the sides and the stake was noted to be damaged and bent.The scratches in the cartridge plate and base were approximately at the same location, which suggests that a foreign object was introduced between the plate and the body, and the bent condition suggests the foreign object was used to force the plate out.

• Brand Name: ENDOSUTURE SYSTEM 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: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 4559743
• MDR Text Key: 18780085
• Report Number: 3005075853-2015-01431
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K972679
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SW110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1