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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SVCE REPL SPIDER 2 TENET 7615; TABLE, OPERATING-ROOM, ELECTRICAL
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SMITH & NEPHEW, INC. SVCE REPL SPIDER 2 TENET 7615; TABLE, OPERATING-ROOM, ELECTRICAL Back to Search Results
Catalog Number 72203299S
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that the device was making weird noises.No patient injury was reported.No back-up device available.
 
Additional Manufacturer Narrative
Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The reassessment determined that the issue does not meet the threshold for reporting and is a non-reportable event.
 
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Brand Name
SVCE REPL SPIDER 2 TENET 7615
Common Device Name
TABLE, OPERATING-ROOM, ELECTRICAL
Manufacturer (Section D)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107 6512
MDR Report Key7676079
Report Number1643264-2018-00529
Device Sequence Number19174999
Product Code GDC
UDI-Device Identifier00885554029673
UDI-Public(01)00885554029673
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
EXEMPT
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 07/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Catalogue Number72203299S
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/26/2018
Supplement Date Received by Manufacturer07/20/2018
Initial Report FDA Received Date07/10/2018
Supplement Report FDA Received Date07/23/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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