MAUDE Adverse Event Report: ETHICON INC. VERSAPOINT RESECTOSCOPIC SYSTEM; HYSTEROSCOPE (AND ACCESSORIES)

Catalog Number 00467

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Wound Dehiscence (1154); Internal Organ Perforation (1987); Pain (1994); Pneumonia (2011); Sepsis (2067); No Code Available (3191)

Event Date 12/08/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further info derived from the evaluation will be submitted in a supplemental 3500a form.

Event Description

It was reported that a patient underwent a gynecological procedure on (b)(6) 2015 and an electrosurgical device was used.After the procedure, the patient presented back to the hospital 2 days later and had an alleged bowel perforation.It was reported that the procedure was completed without a perforation detected.Additional information has been requested.

Manufacturer Narrative

(b)(4).It was reported that the procedure was an endometrial polypectomy.The patient experienced abdominal pain and collapse at home two days after the procedure.Bowel perforation was confirmed during an emergency laparotomy.Additionally, the patient experienced uterine perforation, sepsis, aki, dic, two episodes of pneumonia and thrombocytopenia.The patient underwent repair of small bowel perforation and uterine perforation.Drains were inserted.The patient was treated in intensive care, received dialysis, antibiotics, ventilation, conservative management of a wound dehiscence and remains in inpatient.The patient is also on new medication for depression.The surgeon opines that the cause of this event was due to the electrosurgical device due to location, appearance, necrotic edges and timing.There were no signs of perforation during the procedure.Two days later suggests late diathermy necrosis and late perforation.

• Brand Name: VERSAPOINT RESECTOSCOPIC SYSTEM
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-GYRUS MEDICAL LTD; fortran road, st. mellons; cardiff CF3 O LT; UK CF3 OLT
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 5324993
• MDR Text Key: 34290094
• Report Number: 2210968-2015-21169
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K040302
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 00467
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/11/2016
• Was Device Evaluated by Manufacturer?: No
• 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): Hospitalization; Required Intervention
• Patient Age: 71 YR