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U.S. Department of Health and Human Services

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

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US SURGICAL PUERTO RICO ENDO UNIVERSAL 65 LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
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.

 
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Brand NameENDO UNIVERSAL 65
Type of DeviceLAPAROSCOPE, 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 Key7231981
MDR Text Key98702233
Report Number2647580-2018-00482
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK912097
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,U
Reporter Occupation
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 Received01/31/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number173052
Device Catalogue Number173052
Device LOT NumberP7F0561X
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/12/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/28/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/06/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 01/31/2018 Patient Sequence Number: 1
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