MAUDE Adverse Event Report: GE HEALTHCARE AUSTRIA GMBH & CO OG RIC5-9A-RS; DIAGNOSTIC ULTRASOUND TRANSDUCER

Model Number RIC5-9A-RS

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Vaginal Mucosa Damage (2124)

Event Date 04/22/2022

Event Type  Injury  

Manufacturer Narrative

Gehc has investigated the complaint and forwarded complaint information to civco.It was confirmed the pec63 was manufactured by civco, and the probe by gehc.The probe was manufactured in november of 2021 and does not show signs of wear which would adversely affect the needle guideâs ability to remain clipped to the probe.Additionally, there were no signs of damage to the needle guides.Therefore, gehc has concluded there is no damage to the gehc ric5-9a-rs probe and it is not malfunctioning.Civco has contacted the customer and the customer has agreed to return the needle guides to civco for further analysis.Furthermore, design verification documentation was obtained which reports that a force of 10n, the equivalent of a 1kg weight, was needed to pop the needle guide off the probe.Civco is continuing their investigation, and gehc has completed theirs.Udi (of the ric5-9a-rs): (b)(4).Legal manufacturer (of the ric5-9a-rs): (b)(4).

Event Description

The customer reported that a civco pec63 reusable needle guide popped off a gehc ric5-9a-rs ultrasound probe during a transvaginal procedure, and the patient received a 0.5cm vaginal laceration which required medical intervention (a suture).The customer contacted gehc for support and noted the needle guide does not clamp on (it clips on) and has come off during other procedures when he torques/twists the probe while it is transvaginal.Pictures of the probe and guide were provided to gehc.

• Brand Name: RIC5-9A-RS
• Type of Device: DIAGNOSTIC ULTRASOUND TRANSDUCER
• Manufacturer (Section D): GE HEALTHCARE AUSTRIA GMBH & CO OG; tiefenbach 15; zipf oberosterreich, 4871 ; AU 4871
• Manufacturer (Section G): GE HEALTHCARE AUSTRIA GMBH & CO OG; tiefenbach 15; zipf oberosterreich, 4871 ; AU 4871
• Manufacturer Contact: joseph tamblyn ; 9900 w innovation dr; mail drop: rp-2130 / b4422; wauwatosa, WI 53226-4856
• MDR Report Key: 14465127
• MDR Text Key: 293567818
• Report Number: 8020021-2022-00001
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201828
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: RIC5-9A-RS
• Device Lot Number: PROBE: 278502KR0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female