MAUDE Adverse Event Report: VIVEVE, INC. VIVEVE SYSTEM; ELECTROSURGICAL SYSTEM

Model Number	88003S
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	05/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information was unavailable from the site.Suspect product information is not applicable to this report.The console, handpiece and tips involved in this incident has been received for investigation.Test results have likely ruled out the console as the cause.Additional testing on the handpiece and tips showed that there was a possibility that the cryogen return lumen has been kinked closed when it was attached.Viveve recreated the scenario and was able to recreate the delamination, identifying the kinked handpiece lumen as the likely cause.The built-up pressure of cryogen from the kinked caused the tip electrode to separate from the tip.No failure of the tip would occur under normal operation of the handpiece.If relevant information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported to viveve on 18-may-2021 that a treatment tip delaminated during a treatment causing an abrasion in the vaginal canal.Patient (pt) originally had a treatment scheduled for (b)(6) 2021 but treatment was rescheduled for (b)(6) 2021.Pt returned for their rescheduled treatment ((b)(6) 2021) and a new handpiece (hp) was used.Three tips were used during this treatment, and it is unclear from the site which of the three tips delaminated.During use of all three tips the provider felt a force from the hp toward the provider.The provider also reported an error appeared saying the system stopped delivering rf/cryogen.The pt opted to continue treatment after this occurred with the first and second tip.Upon examination of the third tip, the provider noticed a small amount of blood.The provider examined the pt and reported an abrasion in the vaginal canal.The pt was sent home to rest and the clinic planned follow-up with the pt.The next day ((b)(6) 2021) the pt reported that the day of treatment they had to wear a tampon for bleeding and now they were using a panty liner with little bleeding and no pain.On (b)(6) 2021 the pt came in for a follow-up.The pt was doing well and the abrasion was healing without issues.On (b)(6) 2021 the clinic reported that the abrasion was completely healed, and the pt did not report additional problems.No additional information was provided.

• Brand Name: VIVEVE SYSTEM
• Common Device Name: ELECTROSURGICAL SYSTEM
• Manufacturer (Section D): VIVEVE, INC.; 345 inverness drive south; building b, suite 250; englewood CO 80112 5889
• MDR Report Key: 12001525
• Report Number: 3013565579-2021-00001
• Device Sequence Number: 4439831
• Product Code: GEI
• UDI-Device Identifier: 00850794007132
• UDI-Public: 0850794007132
• Combination Product (Y/N): Y
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K162547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/15/2021

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
• Operator of Device: Health Professional
• Device Model Number: 88003S
• Device Catalogue Number: VIVGE01S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2021
• Initial Report FDA Received Date: 06/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention