MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PROXIMATE*LINEAR STAP RELOAD; STAPLE, IMPLANTABLE

Model Number XR60B

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/29/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.The lot/batch was not provided; therefore, the manufacturing record evaluation could not be performed.

Event Description

It was reported that during an unknown procedure, the packaging was imperfect, the package is opened, it is not under sterile status.The sterility was compromised.There were no patient consequences.

Manufacturer Narrative

(b)(4).Date sent: 04/17/2020.Additional information received: the xr60b is not available to be returned for investigation.

• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 9916810
• MDR Text Key: 198106460
• Report Number: 3005075853-2020-01949
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036013464
• UDI-Public: 10705036013464
• Combination Product (y/n): N
• PMA/PMN Number: K020779
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: XR60B
• Device Catalogue Number: XR60B
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/13/2020
• Patient Sequence Number: 1