MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDOPATH*PROBE PLUS II SHAFT; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Model Number EPS02

Device Problem Use of Device Problem (1670)

Patient Problems Injury (2348); Bowel Perforation (2668)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch # unknown.Investigation summary: as the device was not returned, an analysis investigation could not be performed.A conclusion could not be reached as to what may have caused or contributed to the event.Complaint information is trended on a regular basis to determine if further investigation is warranted.The lot/batch/serial number was not provided; therefore, a manufacturing record evaluation could not be performed.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that, during a laparoscopic ob-gyn procedure, the device was activated when the device tip was not touching the target tissue and capacitive coupling had occurred outside the visual field of scope.In this time, the shaft part was touching the intestine and mesentery.The intestine was damaged and ileocecal perforation was found after the procedure.The device was used to complete the case.The patient was discharged from the hospital.No device will be returning.No further information is available.

Manufacturer Narrative

(b)(4).Date sent: 9/10/2020.Additional information was requested and the following was obtained: were any other energy devices used in this procedure? there is no report about the other energy devices.No further information will be available.Why is it believed that the thermal damaged was caused by the probe plus ii shaft?do they believe the thermal damaged was caused by shaft ? dr.Commented that the shaft part was touching to the intestine and mesentery.No further information will be available.What were the power setting on the generator during the procedure? no further information will be available.Approximately how long was device activated during the surgical procedure? no further information will be available.What heat management techniques were used throughout the procedure? no further information will be available.How was the patient's condition managed? no further information will be available.What is the patient¿s current status? she is already been discharged from the hospital.No further information will be provided.".

• Type of Device: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 10472193
• MDR Text Key: 205118256
• Report Number: 3005075853-2020-04423
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10705036012467
• UDI-Public: 10705036012467
• Combination Product (y/n): N
• PMA/PMN Number: K912492
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/05/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: EPS02
• Device Catalogue Number: EPS02
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/05/2020
• Initial Date FDA Received: 08/31/2020
• Supplement Dates Manufacturer Received: 08/05/2020
• Supplement Dates FDA Received: 09/10/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other