MAUDE Adverse Event Report: COOPERSURGICAL, INC. LEEP PRECISION INTG. SYS.

Model Number LP-10-120

Device Problem Overheating of Device (1437)

Patient Problems Pain (1994); Burn, Thermal (2530)

Event Date 02/22/2018

Event Type  malfunction  

Manufacturer Narrative

Cooper surgical is currently investigating the reported condition.Once the investigation is complete, a follow up report will be filed.(b)(4).

Event Description

Patient cried out in pain during procedure stating "my leg burns." sheet was removed and grounding pad was curled up on all edges, barely applied to patient.2" long linear burn to patients right thing.(b)(4).

Manufacturer Narrative

Coopersurgical is currently investigating the reported condition.Once the investigation is complete a follow up report will be filed.(b)(4) ***update: 04/10/2018*** investigation: *analysis and findings: a review of the 2 yr complaint history reveals no similar issues.A review of the dhr reveals no anomalies.A single pad, p/n 6050p1, was used with the leep precision system.The leep precision system is designed to operate with a dual pad, p/n lp-50-201.However, a loose pad will significantly increase the chances of a burn to occur.Coupled together, like in this case, the root cause is primarily due to end user error.Corrective actions: *correction and/or corrective action : sustaining engineering is evaluating the device to prevent the use of a single pad on the leep precision system.Instructions to handle the use of pad is already stated in the ifu.Any changes to the device will be done in accordance to csi internal verification and validations procedures as they apply.*was the complaint confirmed? no.

Event Description

Patient cried out in pain during procedure stating "my leg burns." sheet was removed and grounding pad was curled up on all edges, barely applied to patient.A 2" long linear burn to patients right thigh.(b)(4).

• Brand Name: LEEP PRECISION INTG. SYS.
• Type of Device: LEEP PRECISION INTG. SYS.
• 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: 7321421
• MDR Text Key: 101957520
• Report Number: 1216677-2018-00007
• Device Sequence Number: 1
• Product Code: HGI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K963348
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: LP-10-120
• Device Catalogue Number: LP-10-120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention