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

Model Number	XR60G
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/29/2019
Type of Reportable Event	Malfunction
Additional 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.
Additional 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 or Problem 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.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 9916821
• Report Number: 3005075853-2020-01950
• Device Sequence Number: 2718114
• Product Code: GDW
• UDI-Device Identifier: 10705036013471
• UDI-Public: 10705036013471
• Combination Product (Y/N): N
• PMA/510(K) Number: K020779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 03/15/2020
• Supplement Date Received by Manufacturer: 04/14/2020
• Initial Report FDA Received Date: 04/02/2020
• Supplement Report FDA Received Date: 04/17/2020
• Patient Sequence Number: 1