MAUDE Adverse Event Report: COOPERSURGICAL, INC. L1000- LEEP SYSTEM 1000- 110V; L1000 - LEEP SYSTEM 1000 - 110V

Model Number L1000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Burning Sensation (2146); Burn, Thermal (2530)

Event Date 06/13/2018

Event Type  malfunction  

Manufacturer Narrative

Cooper surgical inc.Is currently investigating the reported complaint condition.The actual device involved in the complaint has been returned for evaluation by the customer.Once the investigation is completed a follow-up report will be filled.(b)(4).

Event Description

Leep machine was brought into room.All supplies were set up, grounding pad and "wand" was plugged in.Grounding pad attached to patients right thigh.Doctor entered room, after procedure was ready to begin, evacuation tubing attached to speculum.Machine plugged into power bar closest to the machine.Doctor picked out what size leep loop electrode she desired and same was connected to the wand.Machine was turned on and physician completed procedure.Cautery ball was connected to wand, doctor removed ball from patient, and i proceeded to clean the ball as per usual procedure.Physician brushed her knuckle off my arm while i was cleaning the cautery ball and we both immediately pulled away and felt hot burning sensation.Physician completed procedure and incident was reported to appropriate people.Two burn marks, one on nurse and one on physician noted.Both very minor.

Manufacturer Narrative

The complaint condition reported is currently being investigated by coopsersurgical, inc.Once the investigation has been completed, a follow up report will be filed.(b)(4).Analysis and findings : a review of the 2 yr complaint history reveals no similar issues.A review of the dhr reveals no anomalies.Service & repair evaluated the device.It was found to be operating to specifications free of anomalies.A review of the failed description indicated there was an electrical current pathway established as follows: active electrode was in contact with nurse.Nurse was in contact with doctor's arm.Doctor was in contact with the patient's cervix.The patient was in contact with the return electrode.The contact between doctor and nurse is not considered typical.It is also likely the contact on the cervix played a critical role in the shock felt by both persons.An attempt to duplicate the issue revealed there isn't residual energy on the instrument once it is inactivate (not activated).The only time power was detected was when the foot pedal was pressed.The pneumatic mechanism can be activated by slowly pressing onto it or in a firm quick motion.A definitive root cause is not readily available but functional defects on the unit were also not detected.The device has been in service from late 2015 with no record of a return until mid 2018.Given the history of the device, no functional defects were found, and no duplication was possible.It is probable certain conditions were present during the procedure unique to the situation that contributed to the persons being shocked.This would be considered outside the manual (p/n 35787b) content provided with the device.It provides guidance on the proper set ups and the appropriate warnings on having a good understanding of rf current prior to use of the device.Correction and/or corrective action the foot pedal was replaced due to wear signs.No repairs were needed on the unit and it was returned to the customer.This complaint will be entered into the coopersurgical continuous improvement plan (cip).Reason: no applicable correction available to train to at this time.Complaints will be continuously monitored to determine if there is any new trend for this complaint condition.Was the complaint confirmed? no.(b)(4).

Event Description

"physician's knuckle and nurse's hand slight burn while handing the device in off mode.Incident occurred (b)(6) 2018 around 2:00pm.Leep setting at 30w." ref e-complaint- (b)(4).

• Brand Name: L1000- LEEP SYSTEM 1000- 110V
• Type of Device: L1000 - LEEP SYSTEM 1000 - 110V
• Manufacturer (Section D): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer Contact: peter niziolek ; 75 corporate drive; trumbull, CT 06611
• MDR Report Key: 7965137
• MDR Text Key: 123946859
• Report Number: 1216677-2018-00058
• Device Sequence Number: 1
• Product Code: HGI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K952483
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: L1000
• Device Catalogue Number: L1000
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other