MAUDE Adverse Event Report: ETHICON INC. ENDOLOOP LIGATURE WITH COATED VICRYL; LAPROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number XCMIC511G

Device Problem Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problems Nicks, cuts or tears of dura or other tissues by device (1417); Surgical procedure, additional (2564)

Event Date 05/04/2015

Event Type  Injury  

Event Description

It was reported that a patient underwent an appendectomy on (b)(6) 2015 and suture was used.During the procedure, the surgeon placed the ligature at the base of the appendix and pushed the knot normally within the applicator.When removing the applicator, it got stuck in the knot.Consequently, the base of the appendix was torn.The surgeon then sutured the base with a standard suture, buried the stump within the intestine and performed a perioteal cleaning.Additional information has been requested.

Manufacturer Narrative

(b)(4).Conclusion: to date, the device has not been returned.If the product is returned for evaluation, any further info derived from the evaluation will be submitted in a supplemental 3500a form.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

• Brand Name: ENDOLOOP LIGATURE WITH COATED VICRYL
• Type of Device: LAPROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 015
• Manufacturer (Section G): ETHICON INC.-BRAZIL; rodovia presidente dutra, km 1; 54; sao paolo 1224 0-90; BR 12240-908
• Manufacturer Contact: mary szaro ; route 22 west po box 151; somerville, NJ 08876 ; 9082183464
• MDR Report Key: 4808921
• MDR Text Key: 5928682
• Report Number: 2210968-2015-06532
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K925914
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2019
• Device Catalogue Number: XCMIC511G
• Device Lot Number: HLX345
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention