MAUDE Adverse Event Report: COOPERSURGICAL, INC. EEP SYSTEM 1000 ESU GEN

Model Number 52969

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

Patient Problems Burning Sensation (2146); Partial thickness (Second Degree) Burn (2694)

Event Date 11/17/2017

Event Type  Injury  

Manufacturer Narrative

Coopersurgical is currently investigating the complaint condition. Once the investigation is complete, a followup report will be filed. Reference e-complaint-(b)(4). Investigation: analysis and findings: a review of the 2 yr complaint history reveals no similar issues. This unit was shipped out april 3, 2007 with no record of it being returned for service. The complaint condition cannot be confirmed as no unit is being returned. A root cause for this complaint condition is not available. It is likely end user error contributed in the complaint description. The information on the complaint indicates the patient was under during the procedure. This will prevent a patients 'feedback' should they ever feel discomfort or pain. Also, the burns were located at the pad site. Even if a patient is sedated, the ifu directs the end user to regularly ensure the pad is fully in place throughout the procedure. If the pad is not in place fully, the current concentrates in the remaining area still in contact with the patient. The result can be burns if enough of the pad detaches from the skin. Correction and/or corrective action: no applicable corrective actions available. This device is no longer being manufactured as of 2016. This complaint will be entered into the coopersurgical continuous improvement plan (cip). Complaints will be continuously monitored to determine if there is any new trend for this complaint condition. Was the complaint confirmed? no.

Event Description

Leep procedure was done under anesthesia. Patient went home but later felt burning sensation. Patient discovered 2 lesion (2cm and 3 cm long) 2nd degree burn and went to urgent care. Reference e-complaint-(b)(4).

Manufacturer Narrative

Coopersurgical is currently investigating the complaint condition. Once the investigation is complete, a followup report will be filed. (b)(4).

Event Description

Leep procedure was done under anesthesia. Patient went home but later felt burning sensation. Patient discovered 2 lesion ( 2 cm and 3 cm long) 2nd degree burn and went to urgent care. (b)(4).

• Brand Name: EEP SYSTEM 1000 ESU GEN
• Type of Device: EEP SYSTEM 1000 ESU GEN
• Manufacturer (Section D): COOPERSURGICAL, INC.; 75 corporate dr; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate dr; trumbull CT 06611
• Manufacturer Contact: nana banafo ; 75 corporate dr; trumbull, CT 06611 ; 2036015200
• MDR Report Key: 7143198
• MDR Text Key: 256920751
• Report Number: 1216677-2017-00074
• Device Sequence Number: 1
• Product Code: HGI
• Combination Product (y/n): N
• Reporter Country Code: US
• 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

• Type of Report: Initial,Followup
• Report Date: 03/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 52969
• Device Catalogue Number: 52969
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 12/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 12/22/2017 Patient Sequence Number: 1