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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SPIDER2 24V BATTERY CHARGER; BATTERY, REPLACEMENT, RECHARGEABLE
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SMITH & NEPHEW, INC. SPIDER2 24V BATTERY CHARGER; BATTERY, REPLACEMENT, RECHARGEABLE Back to Search Results
Catalog Number 72203840
Device Problem Charging Problem (2892)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/26/2019
Event Type  malfunction  
Event Description
It was reported that during a shoulder scope, the spider battery charger was not charging.The procedure was completed with an allen medical positioner with no significant delay or patient injuries.
 
Manufacturer Narrative
The device was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection was performed on the product and no issues were observed.A functional evaluation revealed the unit does not change from orange to red diode charging mode.The unit¿s power supply was disassembled.The printed circuit board¿s fuse was tested for continuity and tested good.No burned or damaged components were observed on the pcb.The ac wiring and battery clips was tested for continuity and tested good.The complaint has been confirmed and a root cause was a component failure on the pcb.
 
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Brand Name
SPIDER2 24V BATTERY CHARGER
Type of Device
BATTERY, REPLACEMENT, RECHARGEABLE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107 6512
MDR Report Key8545216
MDR Text Key142935514
Report Number1643264-2019-00290
Device Sequence Number1
Product Code MOQ
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 05/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/24/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number72203840
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/25/2019
Date Manufacturer Received05/21/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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