PDB OMS-PDBS2

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-31 for PDB OMS-PDBS2 manufactured by Us Surgical Puerto Rico.

Event Text Entries

[185969586] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[185969587] According to the reporter, while inflating the device during a laparoscopic hernia repair procedure, the balloon got detached from the trocar and fell into the patient's cavity. The balloon was retrieved. The surgical time was extended to 30 minutes or more. There was no patient injury.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2647580-2020-01160
MDR Report Key9908793
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-01
Date Mfgr Received2020-03-13
Device Manufacturer Date2019-11-22
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactLISA HERNANDEZ
Manufacturer Street60 MIDDLETOWN AVE.
Manufacturer CityNORTH HAVEN CT 06473
Manufacturer CountryUS
Manufacturer Postal06473
Manufacturer Phone2034925563
Manufacturer G1US SURGICAL PUERTO RICO
Manufacturer Street201 SABANETAS INDUSTRIAL PARK
Manufacturer CityPONCE PR 007164401
Manufacturer CountryUS
Manufacturer Postal Code007164401
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePDB
Generic NameLASER INSTRUMENT, SURGICAL, POWERED
Product CodeGEX
Date Received2020-03-31
Model NumberOMS-PDBS2
Catalog NumberOMS-PDBS2
Lot NumberP9L1261Y
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerUS SURGICAL PUERTO RICO
Manufacturer Address201 SABANETAS INDUSTRIAL PARK PONCE PR 007164401 US 007164401


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

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