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	10/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # p5892f.Device evaluation summary: the analysis results showed that the tl60 device was received with the hook shroud opened by the seam and with a cartridge loaded on the device.The cartridge was returned fully fired.No functional test could be performed due to the condition of the device.The device was disassembled to verify the condition of the internal components and the device was noted to have the lockout slide tip and the adjusting knob damaged.The damage to the lockout slid tip and knob is consistent with an excessive force applied to the rotating knob when trying to dial down a locked device, causing the damage to the knob.It should be noted that the instrument has been designed with a lockout feature, which during the first application, prevents turning the adjusting knob unless the retaining pin is pushed completely forward.Please reference the instructions for use for additional information.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.Additional information was requested and the following was obtained: surgical procedure.Laparotomy plus gastrectomy.Reason for the surgery.Gastric ulcer.Was there damage / consequences to the patient due to the problem with the device? no.Was there a surgical delay due to the problem with the device? (no, yes and how long).No, the hospital was replenished as soon as possible and the stapler was replaced.Did there exist damage / consequences in the patient due to the surgical delay? no.What is the current status of the patient? discharged by the physician without consequences.Further event information was requested and the following was obtained: can you please clarify the event.When the device "is very hard" was the device difficult to fire? if yes, was the firing completed? if yes, was the staple line complete? was there any issue with the staple formation (unformed, malformed, legs straight)? when "at the time of shooting the device was opened", was the body of the device itself separated? response: the stapler became hard but in the end the dr.Did not shot because he felt tense.I think what happened is that it put too much tissue in the jaws and the pressure was so great that he felt that the stapler was going to open.
Event or Problem Description
It was reported that during a gastrectomy procedure, the stapler is very hard and at the time of shooting the device was opened.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: 8217162
• Report Number: 3005075853-2019-15490
• Device Sequence Number: 1710292
• Product Code: GDW
• UDI-Device Identifier: 10705036013181
• UDI-Public: 10705036013181
• 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): 10/19/2018

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: 09/11/2022
• Device Catalogue Number: TL60
• Device Lot Number: P4T47H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/12/2018
• Initial Report FDA Received Date: 01/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1