MAUDE Adverse Event Report: GE ULTRASOUND KOREA, LTD. VOLUSON P8; DIAGNOSTIC ULTRASOUND IMAGING SYSTEM

Model Number UKVP8B

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/21/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Ge's investigation has completed and concluded the adverse event was the result of an inherent risk of the procedure.

Event Description

It was reported that two patients each were injured on separate dates.This report represents the second patient injury, patient b.The voluson p8 was used for ultrasound biopsy needle guidance during vivo oocyte retrieval (vor).The ultrasound probe used was an ic9-rs probe (s/n (b)(4)) along with a cook medical immature ovum aspiration needle (g44358) for harvesting oocytes.The patient went home, and later in the day went to an operation room for operative laparoscopy and cauterization.

• Brand Name: VOLUSON P8
• Type of Device: DIAGNOSTIC ULTRASOUND IMAGING SYSTEM
• Manufacturer (Section D): GE ULTRASOUND KOREA, LTD.; seeh10; seongnam-si 462-8 07; KS 462-807
• Manufacturer Contact: joseph tamblyn ; 9900 w innovation dr; mail drop: rp-2130 / b4422; wauwatosa, WI
• MDR Report Key: 8651378
• MDR Text Key: 146411587
• Report Number: 9710090-2019-00003
• Device Sequence Number: 1
• Product Code: IYN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180535
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UKVP8B
• Device Lot Number: VP8801216
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other