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

Model Number 52969

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

Patient Problem Burn, Thermal (2530)

Event Date 03/29/2017

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical inc. Is currently investigating the reported complaint condition. The device involved in the complaint will be returned by the customer and evaluated. Once the investigation is completed a follow up report will be filed. (b)(4).

Event Description

(b)(4). Burn mark on patient's leg. Customer reported sn (b)(4)- not a valid number. Will be confirmed once received in at service and repair. Sent to s&r under log # (b)(4).

Manufacturer Narrative

Coopersurgical inc. Is currently investigation the reported complaint condition. The device involved in the complaint will be returned by the customer and evaluated. Once the investigation is completed, a follow up report will be filed. (b)(4). Update 05/05/2017- investigation: x- inspect returned samples. Analysis and findings: a review of the 2 yr complaint history reveals one similar issue. A review of the dhr is not available but not expected to provide useful information for this complaint. This unit was manufactured april 2005. Service & repair did not confirm the complaint. The unit functioned to specifications. The root cause for this complaint is being attributed to end user error. With no functional defects noted on the device it is possible the patient pad came loose enough to cause the complaint condition. Additionally, it is possible the patient was under during the procedure. Corrective actions: the unit operated to specifications and returned to the customer at a charge. This complaint will be entered into the coopersurgical continuous improvement plan (cip).

Event Description

(b)(4). Burn mark on patient's leg. Customer reported sn (b)(4)- not a valid number. Will be confirmed once received in at service and repair. Sent to s&r under log # (b)(4).

• Brand Name: LEEP SYSTEM 1000 ESU GEN.
• Type of Device: LEEP 1000
• Manufacturer (Section D): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer Contact: nana banafo ; 75 corporate drive; trumbull, CT 06611 ; 2036015200
• MDR Report Key: 6464910
• MDR Text Key: 72196157
• Report Number: 1216677-2017-00019
• 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: consumer,health professional

Reporter Occupation

• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 05/05/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/06/2017
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 52969
• Device Catalogue Number: 52969
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2017
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse