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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 173054
Device Problems Loss of or Failure to Bond (1068); Failure to Form Staple (2579)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/04/2020
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

According to the reporter, during a laparoscopic inguinal hernia repair procedure, the devices were able to fire, but staples did not close completely and hold on tissue. Another reload was used to complete the case. There was no patient injury.

 
Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of two devices. Visual inspection of the both product noted no abnormalities. Both instruments were received with a partially applied single use loading unit (sulu) preloaded on the device. The articulation and rotation knobs of both instruments functioned properly. The first instrument was applied to the appropriate test media. The remaining ten staples deployed and seated properly in the appropriate test media. The second instrument was applied to the appropriate test media. The remaining six staples deployed and seated properly in the appropriate test media. Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture. The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition. 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 Key9869612
MDR Text Key184732114
Report Number2647580-2020-01038
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK912097
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 06/03/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/23/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number173054
Device Catalogue Number173054
Device LOT NumberP9D1564Y
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/16/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/28/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/29/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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