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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: US SURGICAL PUERTO RICO AUTO SUTURE LAPAROSCOPE, GENERAL & PLASTIC SURGERY

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US SURGICAL PUERTO RICO AUTO SUTURE LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Model Number OMS-T10SB
Device Problems Seal (432); Material Separation (1562); Detachment of Device or Device Component (2907)
Patient Problem Foreign Body In Patient (2687)
Event Date 07/09/2018
Event Type  Injury  
Manufacturer Narrative

Occupation: health professional (hpro). If information is provided in the future, a supplemental report will be issued.

 
Event Description

According to the reporter, during a laparoscopic inguinal hernia total extra peritoneal, during mesh insertion in the extra peritoneal area, the valve seal disengaged. The surgical time was extended by about an hour and a half due to the product problem and the surgeon looked for the seal in the body to complete the case. The device component was not retrieved.

 
Manufacturer Narrative

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

 
Search Alerts/Recalls

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Brand NameAUTO SUTURE
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 Key7718039
MDR Text Key114958531
Report Number2647580-2018-03708
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Reporter Country CodeIS
PMA/PMN NumberK924011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/03/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/25/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberOMS-T10SB
Device Catalogue NumberOMS-T10SB
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/08/2018
Was Device Evaluated By Manufacturer? No Answer Provided
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: 07/25/2018 Patient Sequence Number: 1
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