MAUDE Adverse Event Report: GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI) VOLUSON P6 W/E8C-RS PROBE; ULTRASONIC DIAGNOSTIC TRANSDUCER

Model Number E8C-RS PROBE

Device Problems Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Laceration(s) (1946); Uterine Perforation (2121)

Event Date 10/04/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Ge healthcare's investigation is ongoing.A follow up report will be submitted after the investigation has been completed.

Event Description

It was reported from a customer that a hemorrhage to a female patient occurred while undergoing an ovarian biopsy when the ovary was punctured and/or torn with the biopsy needle.An e8c-rs ultrasound probe, along with a voluson p6 and a biopsy needle guide model e721 were being used to assist in the ovarian biopsy.The user reported that the visual guide for the needle was offset and therefore needle placement was incorrect.

Manufacturer Narrative

Ge service was able to review the incident with the customer at their facility.No images or additional information was provided by the customer.Via visual inspection it was confirmed there was no malfunction of the scanner, probe or biopsy guide, and all were functioning as intended.Additionally, the customer reported that all subsequent ovarian biopsies have proceeded without incident.Lastly, a member of ge's local clinical applications team reviewed known limitations and techniques of the biopsy needle & guideline placement presented within the image by the scanner with the customer to ensure the customer was satisfied with the equipment and the training they had received at an earlier date.No further action is required at this time.

• Brand Name: VOLUSON P6 W/E8C-RS PROBE
• Type of Device: ULTRASONIC DIAGNOSTIC TRANSDUCER
• Manufacturer (Section D): GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI); no. 19 changjiang road; national hi-tech dev. zone; wuxi ; CH
• Manufacturer Contact: joseph tamblyn ; 9900 w. innovation dr.; mail drop rp-2138; wauwatosa, WI
• MDR Report Key: 6999646
• MDR Text Key: 90981563
• Report Number: 9710602-2017-00281
• Device Sequence Number: 1
• Product Code: IYO
• Combination Product (y/n): N
• PMA/PMN Number: K160162
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 12/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: E8C-RS PROBE
• Device Lot Number: 600063WX2/249797SU2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/1970
• 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