MAUDE Adverse Event Report: STORZ MEDICAL AG D-ACTOR 100; RADIAL SHOCKWAVE DEVICE

Model Number 23300

Device Problem Use of Device Problem (1670)

Patient Problem Tinnitus (2103)

Event Date 10/05/2021

Event Type  Injury  

Manufacturer Narrative

No device problem found.Incident most likely due to misuse of device by non-healthcare professional.No ear protection was used, chosen energy settings were reportedly to high, and "simulated patient" was reportedly not asked for feedback regarding treatment intensity or pain / discomfort.

Event Description

During a device demonstration, a sales representative was treating a volunteer (a "mock patient" without pre-existing neck problems) next to the cervical spine (height c3-c4) with the radial shockwave device d-actor 100 with spine applicator tip 3 at 2.0 bar with 2000 shots.D-actor is a device for prescription use only under (21 cfr 801 subpart d), i.E., for use only by a licensed practitioner (i.E.Ifu intended exclusively for use by health care professional).The sales representative is not a licensed practitioner, nor a health care professional, so he should not have used the device on humans.The volunteer was not offered ear protection as recommended in the ifu.It has also been reported that even though the volunteer`s teeth were chattering during treatment, she has not been asked for feedback regarding treatment intensity or pain / discomfort.Apparently, the chosen energy level / patient positioning was not appropriate for that particular patient.As per ifu, treatment should always start at a low energy level that should be increased gradually during treatment.Furthermore, treatment was applied to the spinal column and/or vertebrae and the ifu asks users to take caution when treating these areas.The volunteer reported ringing in the ears immediately after treatment.Right ear ceased to ring after 24 hours, but left ear was still ringing after 8 days.Volunteer went to eent and was prescribed steroid medication (methylprednisone 4mg).No additional patient information could be obtained.The device has been tested and no problems were detected on performance or noise level.

• Brand Name: D-ACTOR 100
• Type of Device: RADIAL SHOCKWAVE DEVICE
• Manufacturer (Section D): STORZ MEDICAL AG; lohstampfestrasse 8; taegerwilen, thurgau 8274 ; SZ 8274
• Manufacturer Contact: markus huebscher ; lohstampfestrasse 8; taegerwilen, thurgau 8274 ; SZ 8274
• MDR Report Key: 12927541
• MDR Text Key: 283497561
• Report Number: 3002808188-2021-00001
• Device Sequence Number: 1
• Product Code: ISA
• UDI-Device Identifier: 07630039101060
• UDI-Public: (01)07630039101060(11)210609
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173692
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 23300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 44 YR
• Patient Sex: Female
• Patient Weight: 68 KG