MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. RENASYS TOUCH NON CONNECT 4TH ED DEVICE; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Catalog Number 66802134

Device Problem Protective Measures Problem (3015)

Patient Problems Impaired Healing (2378); No Code Available (3191)

Event Date 10/12/2020

Event Type  Injury  

Event Description

It was reported that the device was displaying "maintenance error".This is the second time that therapy has been stopped causing a slowdown in healing.Patient injured was reported and there was change in surgical technique.

Manufacturer Narrative

H3, h6: the device, intended for use in treatment, was returned for evaluation.A visual inspection was performed with a scratched back enclosure reported.Functional assessment was performed and showed the failure 4006, coin cell is empty.We have established a relationship between the reported event and the device.Renasys touch has two battery sources, the main battery is rechargeable.The coin cell battery maintains time and date settings if the main battery is depleted.When the coin cell battery becomes fully depleted, error 4006 message is displayed.The device will no longer function and will not charge.Root cause was traced to maintenance.Our clinical investigation concluded: it was communicated that ¿another surgical technique was chosen because of the interruption of the device.¿ without the requested clinical information, a thorough medical investigation cannot be rendered.The other surgical technique used to treat the reported delayed healing is unknown.The patient impact could not be determined based on the limited information provided.Should any additional clinical information be provided this complaint will be re-evaluated.No further clinical/medical assessment is warranted at this time.The manufacturing records show no evidence that the product did not meet specification at the time of manufacture.The complaint history review found further instances of the reported event in the past years.The ifu has been reviewed and contains comprehensive instructions on the safe operation and use of the device.The associated risk files contain details relating to harm.This investigation is now complete with no further action deemed necessary.Smith + nephew will continue to monitor for any adverse trends relating to this product range.

• Brand Name: RENASYS TOUCH NON CONNECT 4TH ED DEVICE
• Type of Device: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• MDR Report Key: 10799963
• MDR Text Key: 214995823
• Report Number: 8043484-2020-03771
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• PMA/PMN Number: K181204
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 03/06/2021

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 66802134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2020
• Initial Date Manufacturer Received: 10/12/2020
• Initial Date FDA Received: 11/06/2020
• Supplement Dates Manufacturer Received: 02/25/2021
• Supplement Dates FDA Received: 03/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention