MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PROXIMATE*75MM LINEAR CUTTER; STAPLE, IMPLANTABLE

Model Number TLC75

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date of event: month and day unknown.Only year (2020) is known.Batch #unk.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.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.

Event Description

It was reported that during an unknown procedure, the blister packaging not properly sealed.There were no patient consequences reported.

Manufacturer Narrative

(b)(4).Date sent: 03/17/2020.Device analysis: the analysis results found that tlc75 device was returned with the tyvek not properly seal from a corner on the blister, however, the sealed area is observed with a complete seal trace.No conclusion could be reached as to how the packaging was opened.It should be noted that as part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.

• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 9674211
• MDR Text Key: 199897792
• Report Number: 3005075853-2020-00789
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036013211
• UDI-Public: 10705036013211
• Combination Product (y/n): N
• PMA/PMN Number: K020779
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TLC75
• Device Catalogue Number: TLC75
• Device Lot Number: T4117K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2020
• Date Manufacturer Received: 02/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1