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	04/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # p58c9l.Photographic evaluation: one photo was provided.The picture shows the distal part of the device, the device appears to be in its sterile package a reload is visible and not loaded on the device.Based on the photo alone the event describe is confirmed.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.Device evaluation: the analysis results found that the device was returned inside its package unopened.Upon visual inspection, the cartridge was observed to be loose inside the package.No conclusion could be reached as to what may have caused the reported incident.The reported complaint was confirmed.Lot p4t55f: the lot history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the packaging process.Batch p58c9l: 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 an unknown procedure, before opened the sterile packing, found the cartridge detached from the device as the photo shows.Another device was used to complete the surgery.There were no adverse consequences to the patient.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 7579755
• Report Number: 3005075853-2018-10429
• Device Sequence Number: 2292371
• 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
• Report Date (Section B): 04/18/2018

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: 09/30/2022
• Device Catalogue Number: TLH30
• Device Lot Number: P4T55F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2018
• Initial Date Received by Manufacturer: 05/14/2018
• Initial Report FDA Received Date: 06/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1