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

Catalog Number EZ10G

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/02/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Was there any rip, hole, tear in the package? was there damage to the primary package that does not compromise sterility (includes tyvek or seal damage that does not compromise sterility)? was sterility compromised? was there any delamination? what area of the package did it not seem completely sealed? are there any pictures available?.

Event Description

It was reported the healthcare professional that prior to an unknown procedure, the packaging does not seem to be completely sealed.It is unknown how the procedure was completed.There were no adverse consequences for the patient reported.Additional information has been requested.

Manufacturer Narrative

Additional information was requested but was unavailable.The actual sample was received for evaluation.During the visual inspection of the open foil the seal area was examined and the foil was properly sealed and conforming to requirements.Due to the sample condition, we are unable to investigate further as the sample was returned open.

• Brand Name: ENDOLOOP LIGATURE WITH PDS II
• 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: darlene kyle ; route 22 west po box 151; somerville, NJ 08876 ; 9082182792
• MDR Report Key: 6575856
• MDR Text Key: 75467158
• Report Number: 2210968-2017-32161
• Device Sequence Number: 1
• Product Code: GEA
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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,Followup
• Report Date: 05/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: EZ10G
• Device Lot Number: AF3434
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2016
• 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