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

Model Number	TCD75
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pc (b)(4).Only event year known: 2020.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-conformances were identified.If information is obtained that was not available for the initial report, a follow-up report will be field as appropriate.
Event or Problem Description
It was reported that during an unknown procedure, when the nurse opened the paper box and took out the inner package, the stapler was wrongly positioned inside the inner package, diagonally and tip of the instrument was sealed between the paper and plastic sealing so that distal tip of the instrument was seen and package was not sterile anymore.Currently the package is a bit more opened then it was in the beginning, because nurse opened it a bit more.So- the summary of the problem was that instrument arrived as non-sterile because one corner was not sealed.There were no patient consequences.
Additional Manufacturer Narrative
(b)(4).Date sent: 03/19/2021.Per photographic evaluation: during the visual analysis of three photos, the following was observed: the first photo shows a device inside of its package with a gold reload loaded.The second photo shows a package from front area and the tyvek was noted open on the corner of package.However, the seal area on the blister was noted completed.The third photo shows a package from top view of lot#: u4050l, exp.Date: 2025-01-31.The tyvek was noted up of the corner left.Based on the photos reviewed, the event describe is confirmed, however no conclusion or root cause could be determined.As the device was not returned, an analysis investigation could not be performed.  a conclusion could not be reached as to what may have caused or contributed to the event. .
Additional Manufacturer Narrative
(b)(4).Date sent: 04/01/2021 h11: corrected data = updated report submission due date and g3.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 10984296
• Report Number: 3005075853-2020-06627
• Device Sequence Number: 2652283
• Product Code: GDW
• UDI-Device Identifier: 10705036013112
• UDI-Public: 10705036013112
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/20/2020

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: 01/31/2025
• Device Model Number: TCD75
• Device Catalogue Number: TCD75
• Device Lot Number: U4050L
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/20/2020
• Supplement Date Received by Manufacturer: 03/14/2021; 11/25/2020
• Initial Report FDA Received Date: 12/10/2020
• Supplement Report FDA Received Date: 03/19/2021; 04/01/2021
• Patient Sequence Number: 1