MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PROXIMATE*RL TITANIUM 30MM; STAPLE, IMPLANTABLE

Catalog Number	TL30
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # p5635t.Device evaluation: the analysis results showed that the tl30 device arrived with no apparent damaged and with a reload loaded in the device.The reload was received partially loaded with only 2 staples present.The device was tested for functionality with a test reload and it fired and formed all the staples as intended.The device fired without any difficulties and the staples were noted to have a proper b-formation.It should be noted that when manipulating the device only the closing trigger should be grasp until ready to fire the device.Do not grasp the firing trigger before the device is to be fired.If the firing trigger is manipulated it could cause the staples to deploy partially or completely resulting in malformed staples and a premature lockout situation.For further details please refer to the instruction for use.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.
Event or Problem Description
It was reported that during a retosigmoidectomy procedure, during handling of the stapler, there was extrusion and release of the clamps before the drive, method by which we requested new stapler in order to finish the procedure.There were no patient consequences reported.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 7776597
• Report Number: 3005075853-2018-12039
• Device Sequence Number: 2447333
• Product Code: GDW
• UDI-Device Identifier: 20705036013164
• UDI-Public: 20705036013164
• 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): 03/29/2018

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: 03/01/2022
• Device Catalogue Number: TL30
• Device Lot Number: P4RV25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/16/2018
• Initial Report FDA Received Date: 08/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1