MAUDE Adverse Event Report: US SURGICAL PUERTO RICO ENDO UNIVERSAL 65; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number 173052

Device Problems Entrapment of Device (1212); Physical Resistance (2578); Failure to Form Staple (2579)

Patient Problems Tissue Damage (2104); No Code Available (3191)

Event Date 01/10/2018

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during a laparoscopy assisted distal gastrectomy, on the first firing to fix the tissue temporarily prior to reconstruction, surgeon started to fire the device but felt some differences in squeezing the handle.It was noted that the staples were not formed properly and stuck in the cartridge, and the handle locked on the tissue.As the device was unable to be removed from the tissue, surgeon resected a small part of the tissue where the device were stuck.Oozing bleeding occurred as a result of the issue.The procedure was completed with another device.The current status of the patient is no problem.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Visual inspection of the instrument noted no visual abnormalities.The dlu was received partially applied.The device was able to articulate and rotate properly.The tacks seated properly, but handle did not retract after firing.The leaf spring was loose on handle.The unit was opened as instructed by engineering and it was noted the leaf spring was detached and rolled.Additionally, the spring retainer was broken.A review of the device history record indicates this product was released meeting all quality release specifications at the time of manufacture.However, an assembly error was identified during product analysis.Root cause of the reported condition is due to an excessive amount of adhesive being applied to the spring retainer during the assembly process.The additional adhesive prevented the spring retainer from properly functioning and resulted in it breaking.A broken spring retainer will prevent the return of the handle after actuating, thus preventing the unit from firing.The product analysis established a relationship between a device failure and the reported incident of instrument did not fire.The root cause of the observed condition was determined to be a result of a manufacturing activity and a process improvement has been initiated to prevent this condition from recurring.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDO UNIVERSAL 65
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer (Section G): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer Contact: lisa hernandez ; 60 middletown ave; north haven, CT 06473 ; 2034925563
• MDR Report Key: 7231981
• MDR Text Key: 98702233
• Report Number: 2647580-2018-00482
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K912097
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: 173052
• Device Catalogue Number: 173052
• Device Lot Number: P7F0561X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention