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

Catalog Number EJ10G

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/01/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Only year of the event is known, ((b)(6) 2016) that complaint was reported.In addition, a review of the batch manufacturing records was conducted in the visual inspection of photo: it was identified, that the lot expiration date was printed in the product box in (b)(4) (abr20) instead of english (apr20).The calculation of the expiration data is correct.

Event Description

It was reported that the device had the expiration date on the primary package printed as exp abr20.There were no adverse patient consequences reported.No further information available.

• 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 0151
• Manufacturer (Section G): ETHICON INC.-BRAZIL; rodovia presidente dutra, km 1; 54; sao paolo 12240 -908; BR 12240-908
• Manufacturer Contact: kenneth clark ; route 22 westp o box 151; somerville, NJ 08876 ; 9082183547
• MDR Report Key: 5679149
• MDR Text Key: 45916665
• Report Number: 2210968-2016-09228
• Device Sequence Number: 1
• Product Code: GEA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K925914
• 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: 05/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: EJ10G
• Device Lot Number: AA5016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2015
• 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