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

Catalog Number	TL60
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.The lot history records were reviewed and the manufacturing criteria were met prior to the release of the lot.
Event or Problem Description
It was reported that during a laparoscopic right hemicolectomy, in the middle of the case, the surgeon fired the device but no staples were deployed.Upon examination, no staples were seen on the specimen either, closer view indicated that the stapling device didn't have any staples.The surgeon wanted to send the specimen to the lab for examination under the microscope.No delay in surgery.There were no patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Batch # p5892f.Device evaluation: the analysis results showed that the tl60 device arrived with no apparent damage and with a reload present.The reload was received fully fired.The device was tested for functionality with a test reload (tl60, gg4074) and it fired and formed all the staples as intended.The device fired without any difficulties, the staples were noted to have a proper b-formation and the staple line was complete.It should be noted that all devices are inspected 100% for staple presence by an automated vision system, and are visually inspected 100% as a final check.In addition, at finished goods the devices are visually inspected based on a sample.This report is not intended to deny that you experienced a problem with the device.There may have been other circumstances or issues that occurred during the use of the device that we were unable to duplicate during our laboratory analysis.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 7288937
• Report Number: 3005075853-2018-08127
• Device Sequence Number: 1342938
• Product Code: GDW
• UDI-Device Identifier: 20705036013188
• UDI-Public: 20705036013188
• 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): 02/01/2018

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: TL60
• Device Lot Number: P4T47H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2018
• Initial Date Received by Manufacturer: 02/01/2018
• Supplement Date Received by Manufacturer: 03/01/2018
• Initial Report FDA Received Date: 02/22/2018
• Supplement Report FDA Received Date: 03/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1