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

Model Number	7210165
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Codes	Fever (1858); Septic Shock (2068); Blood Loss (2597); Bowel Perforation (2668); No Code Available (3191)
Date of Event	08/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem 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
• Common Device Name: INSUFFLATOR, HYSTEROSCOPIC
• Manufacturer (Section D): COVIDIEN MANSFIELD; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 10490859
• Report Number: 1282497-2020-00034
• Device Sequence Number: 3119663
• Product Code: HIG
• UDI-Device Identifier: 03596010529541
• UDI-Public: 03596010529541
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K031616
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 7210165
• Device Catalogue Number: 7210165
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2020
• Initial Report FDA Received Date: 09/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 58 YR