MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CONTROL UNIT, DYONICS 25; CLAMP, CIRCUMCISION

Model Number 7211010

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Swelling/ Edema (4577)

Event Date 08/15/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that during an arthroscopy, the pressure of the dyonics control unit was too high even though it was set to only 30, causing the shoulder to swell.The procedure was completed with non-significant delay using a back-up device.No further complications were reported.

Manufacturer Narrative

H6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.There was no way to determine if the device contributed to the reported event.An analysis of the customer provided image confirmed the part number and serial number but provided no functional information a review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review found similar reported events.A risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.Based on the information provided, as of the date of this medical investigation, the requested clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the event.One undated, unlabeled photo was provided of the back of a dyonics control unit, however, without the return of the device the root cause of the reported failure cannot be determined.According to the report, the procedure was completed with a non-significant delay using a back-up device.The impact to the patient beyond that which has already reported cannot be confirmed nor concluded.Should any additional relevant medical information be provided, this case would be re-assessed.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.The complaint was confirmed, and the root cause was associated with an electrical component failure.Factors which could have contributed to the reported event include a defective transducer.Please refer to the operations/service manual for troubleshooting guidance if poor or erratic pressure performance is observed.No containment or corrective actions are recommended at this time.

• Brand Name: CONTROL UNIT, DYONICS 25
• Type of Device: CLAMP, CIRCUMCISION
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 15357691
• MDR Text Key: 299273035
• Report Number: 1643264-2022-00315
• Device Sequence Number: 1
• Product Code: HFX
• UDI-Device Identifier: 03596010543554
• UDI-Public: 03596010543554
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K171794
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7211010
• Device Catalogue Number: 7211010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other