MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PROXIMATE*RL TITAN HEAVY WIRE; STAPLE, IMPLANTABLE

Catalog Number	TLH30
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Photo evaluation summary: upon visual inspection of a photo, the following was observed: the photo shows a linear stapler inside of its package from top view and it was noted with reload no loaded and black reload can be seen loose inside the package.Based on the photo reviewed, the event describe is confirmed, however no conclusion or root cause could be determined.Device evaluation summary: the analysis results showed that the tlh30 device was received sterile with a reload loose inside the sterile package.Although no conclusion could be reach on what caused the reload to eject from the device, it is possible that the package was submitted to higher forces then normal during transportation allowing the cartridge to disengage from the device.It should be noted that a 100% inspections takes place during manufacturing to ensure the device meets the require 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 during the open lobotomy surgery, did not open the packing, noted the cartridge fell off as the photo shows.Another device was used to complete the surgery.There were no adverse consequences to the patient.No additional information could be provided.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 9364831
• Report Number: 3005075853-2019-23726
• Device Sequence Number: 19733901
• Product Code: GDW
• UDI-Device Identifier: 10705036013228
• UDI-Public: 10705036013228
• 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
• Report Date (Section B): 10/31/2019

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: 06/30/2021
• Device Catalogue Number: TLH30
• Device Lot Number: N4LV3J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/31/2019
• Initial Report FDA Received Date: 11/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1