MAUDE Adverse Event Report: COVIDIEN MANSFIELD HYSTEROSCOPIC FLUID MANAGEMENT SYSTEM STAND; INSUFFLATOR, HYSTEROSCOPIC

Model Number 7210165

Device Problem Incorrect Measurement (1383)

Patient Problems Fever (1858); Septic Shock (2068); Blood Loss (2597); Bowel Perforation (2668); No Code Available (3191)

Event Date 08/11/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during hysteroscopic myomectomy, the surgeon used a combination of instruments to remove myoma's.Bovie pencil and truclear dense shaver (which was not defective.Used for resection only).Large pieces were removed.Patient had bleeding from where these myoma portions were joined to the cervix.Surgeon sutured the cervix to stop the bleeding.The blood loss was noted to be 1 liter.Also noted was there was more fluid output than there was fluid input.Fluid scale numbers were negative throughout procedure.Manual counts of fluid were performed.Hemoglobin and hematocrict count was ordered, hemoglobin was ~ 13 (pre-operative was ~ 14).The bowel of the patient perforated and currently in colostomy bag.The patient had 102 degrees of fever day after the procedure, instructed to go to emergency room but did not come immediately.The following day, patient was taken to other hospital emergency room and found to be in sepsis shock and not producing urine.They free the fluid in the abdomen and a perforation seen in the sigmoid.The patient was released to emergency room 1-2 days later.

• Brand Name: HYSTEROSCOPIC FLUID MANAGEMENT SYSTEM STAND
• Type of Device: INSUFFLATOR, HYSTEROSCOPIC
• Manufacturer (Section D): COVIDIEN MANSFIELD; 15 hampshire street; mansfield MA 02048
• Manufacturer (Section G): COVIDIEN MANSFIELD; 15 hampshire street; mansfield MA 02048
• Manufacturer Contact: lisa hernandez ; 5920 longbow drive; boulder, CO 80301 ; 2034925563
• MDR Report Key: 10490859
• MDR Text Key: 207335854
• Report Number: 1282497-2020-00034
• Device Sequence Number: 1
• Product Code: HIG
• UDI-Device Identifier: 03596010529541
• UDI-Public: 03596010529541
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031616
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7210165
• Device Catalogue Number: 7210165
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR