MAUDE Adverse Event Report: SURGI SUPPLIES MCCARTNEY TUBE

Model Number 35-TV

Device Problem Insufficient Information (3190)

Patient Problem Laceration(s) (1946)

Event Date 06/28/2017

Event Type  Injury  

Event Description

Device details: device description: mccartney tube¿.Device code/identifier: 35-tv.Lot/batch: 3522116.Patient details: (b)(6) female with endometrial cancer.Prior surgery unknown and not provided following our request.Description of event: during total laparoscopic hysterectomy (tlh) using the mccartney tube¿, a small vaginal laceration was found on the palatal vagina which required intervention for wound closure.Details from surgeon: "difficulty in treatment was anticipated beforehand and patient's tissue was in a more vulnerable state than usual.Since it was a malignant disease, we wanted to select manipulation in the tube.If not this device with material flexibility, it was probably difficult to keep the laceration within the proximal part of vagina, and make the recovery possible".

• Brand Name: MCCARTNEY TUBE
• Type of Device: MCCARTNEY TUBE
• Manufacturer (Section D): SURGI SUPPLIES; 3/29 macquarie drive; thomastown, victoria 2803 ; AS 2803
• Manufacturer Contact: kelly spurge ; 1/32 silkwood rise; carrum downs, 3201 ; AS 3201
• MDR Report Key: 6819289
• MDR Text Key: 83608432
• Report Number: 3008254127-2017-00002
• Device Sequence Number: 1
• Product Code: HEW
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: 051594
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/02/2017,08/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 03/01/2020
• Device Model Number: 35-TV
• Device Lot Number: 3522116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/02/2017
• Date Manufacturer Received: 08/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR