MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. RENASYS GO; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Model Number	66021496
Medical Device Problem Codes	Arcing (2583); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during wound therapy, a head of the charger of a renasys go was observed to be stuck inside.The customer stated it looked "like a toilet paper roll" and that she noticed when she saw a spark.It is unknown if/how therapy was completed.No further information is available.
Additional Manufacturer Narrative
H3, h6.The device was returned for evaluation confirming the reported event.A visual and functional evaluation was performed the plastic guide was observed to be broken, the device was observed to spark, when plugged in and power applied.A causal affect of this defect was the device could not be charged.A documentation review was performed.Historical review has revealed previous cases of a similar nature, there are no open nor closed escalation actions within the scope of this event type.Risk management files adequately mitigate the event, no updates are required.The manufacturing records reveal no contributory factors, the records detail this device met the finished product specification prior to release into distribution.The probable cause for the sparking observed is that the dc inlet port had become worn form use rendering the component defective.No manufacturing quality concerns have been observed, therefore no corrective actions are deemed necessary, smith and nephew will continue to monitor for adverse trends.
Event or Problem Description
It was reported that, during wound therapy, a head of the charger of a renasys go was observed to be stuck inside.The customer stated it looked "like a toilet paper roll" and that she noticed when she saw a spark.It is unknown if/how therapy was completed.No further information is available.Upon product evaluation, it was determined that the dc inlet port (the part observed to be stuck inside) has become worn from use and caused the arcing/spark.

• Brand Name: RENASYS GO
• Common Device Name: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 14980292
• Report Number: 8043484-2022-00179
• Device Sequence Number: 12220218
• Product Code: OMP
• UDI-Device Identifier: 05000223491000
• UDI-Public: 05000223491000
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K152163
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 66021496
• Device Catalogue Number: 66021496
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2022
• Supplement Date Received by Manufacturer: 12/15/2022
• Initial Report FDA Received Date: 07/11/2022
• Supplement Report FDA Received Date: 12/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Sex: Female