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

Model Number	TCT75
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Only event year known: 2022.Additional information was requested, and the following was received: was part of the packaging found to be damaged (tyvek, plastic/blister, packaging seal, etc.)? tyvek was broken.Or, was there difficulty opening the packaging material (difficulty removing/peeling back the tyvek)? none.Could you please identify the packaging (primary packaging, box, pouch seal or the plastic bag)? when circulation nurse wanted to open the product, she noticed that the tyvek was broken.Could you please clarify the type of damage found (broken, packaging was worn, bent, ragged, contain cut or slit, or appear ripped)? tyvek was broken.5.Did the damage of the primary packaging compromise the sterility of the device? none.Analysis: the product was returned to ethicon endo-surgery for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that the tct75 device was returned outside of its packaging along with a tyvek.Upon visual inspection, it was observed that the tyvek was damaged (ripped); the damage found compromised the device's sterility.The reported event is confirmed.Due to the damages found on the packaging, a possible cause for this condition is due to improper handling during transit or storage; it appears that the package hit a hard surface, and this caused the reported event.Please reference the instruction for use for more information.As part of ethicon endo surgery¿s quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.
Event or Problem Description
It was reported that the package was broken.There were no patient consequences.Procedure: unknown.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo ; * ; 6107428552
• MDR Report Key: 13667396
• Report Number: 3005075853-2022-01338
• Device Sequence Number: 11950903
• Product Code: GDW
• UDI-Device Identifier: 10705036013150
• UDI-Public: 10705036013150
• Combination Product (Y/N): N
• PMA/510(K) Number: K020779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/04/2022

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: 01/31/2026
• Device Model Number: TCT75
• Device Catalogue Number: TCT75
• Device Lot Number: 143A96
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/11/2022
• Initial Report FDA Received Date: 03/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown