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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: US SURGICAL PUERTO RICO SURGIWAND II; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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US SURGICAL PUERTO RICO SURGIWAND II; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES Back to Search Results
Model Number 178099
Medical Device Problem Codes Detachment of Device or Device Component (2907); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 04/28/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, during irrigation of abdominal cavity on a laparoscopic appendectomy, it was noted that there was a foreign object that came from the device that fell into patient's cavity.
 
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Brand Name
SURGIWAND II
Common Device Name
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Manufacturer (Section D)
US SURGICAL PUERTO RICO
201 sabanetas industrial park
ponce PR 00716 4401
MDR Report Key10058293
Report Number2647580-2020-01567
Device Sequence Number19567470
Product Code GEI
UDI-Device Identifier10884523000931
UDI-Public10884523000931
Combination Product (Y/N)N
Initial Reporter CountryKS
PMA/510(K) Number
K961771
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 05/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number178099
Device Catalogue Number178099
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/29/2020
Initial Report FDA Received Date05/14/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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