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	05/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # p56f1p.The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot and batch.
Event or Problem Description
It was reported that during a gastric procedure, the most excision of open ulceration of gastric ulcer, after fired, found no staple.Another device was used to complete the surgery.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
(b)(4).Batch # p56f1p.Device evaluation: the analysis results showed that the tlh30 device arrived with no apparent damage with a reload loaded on the device.The reload was returned void of staples.The device was tested for functionality with a test reload and it cycled, fired, and all the staples formed as intended.The device fired without any difficulties and the staples were noted to have the proper b-formed shape.The event described could not be confirmed as the device performed without any difficulties noted.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.Performed by (b)(6).

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 7602970
• Report Number: 3005075853-2018-10646
• Device Sequence Number: 1759668
• Product Code: GDW
• UDI-Device Identifier: 20705036013225
• UDI-Public: 20705036013225
• 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): 05/22/2018

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: 03/28/2022
• Device Catalogue Number: TLH30
• Device Lot Number: P4T228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2018
• Initial Date Received by Manufacturer: 05/22/2018
• Supplement Date Received by Manufacturer: 07/04/2018
• Initial Report FDA Received Date: 06/14/2018
• Supplement Report FDA Received Date: 07/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention