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

Model Number XR60G

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).Device analysis: the analysis results found that a xr60g cartridge was returned inside the package without apparent damage.Upon visual inspection the packaging was returned partially opened and no anomalies were noted on the package.Event could not be confirmed as no damaged was noted.The reported complaint could not be confirmed.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.

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.

• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo 00969 ; 6107428552
• MDR Report Key: 9916821
• MDR Text Key: 189745179
• Report Number: 3005075853-2020-01950
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036013471
• UDI-Public: 10705036013471
• 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
• Reporter Occupation: Other
• 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 Expiration Date: 04/30/2020
• Device Model Number: XR60G
• Device Catalogue Number: XR60G
• Device Lot Number: M4HJ5V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2020
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/14/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1