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

Model Number LP-10-120

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 10/27/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

"this customer used their leep precision system for the first time and every time that dr.(b)(6) tried to blend or coag the system had the "rf leakage" error and would not function.The cut function worked fine.The doctor had to use silver nitrate on the patient to stop the bleeding.This order was placed (b)(6) and again this was the first case for this leep system.The patient was not adversely affected due to the malfunction." (b)(4).

Manufacturer Narrative

Coopersurgical is currently investigating the complaint condition.Once the investigation is complete a follow up report will be filed.Reference e-complaint-(b)(4).Update: 1/5/2018.Investigation.Analysis and findings: a review of the 2 yr complaint history reveals one similar issue.A review of the dhr reveals the use of variances on the build.The variances were for the use up of non-rohs boards on the integration unit and for the proper fast-on crimps to use in the assembly.Neither indicates a correlation to the failure described on 1 of the 14 units built under wo #224637.The complaint was not confirmed by service & repair and operated to specifications.The root cause for this complaint condition is not reliably determined but potentially due to end user error.The customer may had incorrectly operated the unit or incorrectly set up the device for use.Correction and/or corrective action: the unit was confirmed to operate to specifications.Although the unit functioned and the complaint could not be duplicated it was not re-stocked and scrapped out.The customer received a new unit.The customer was asked for follow up questions by sustaining engineering but no significant information was garnered.The customer confirmed the replacement unit was being used in the same manner with no issues.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.

Event Description

"this customer used their leep precision system for the first time and every time that dr.Ritchie tried to blend or coag the system had the "rf leakage" error and would not function.The cut function worked fine.The doctor had to use silver nitrate on the patient to stop the bleeding.This order was placed 8/11 and again this was the first case for this leep system.The patient was not adversely affected due to the malfunction." reference e-complaint-(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: 6991393
• MDR Text Key: 91452736
• Report Number: 1216677-2017-00068
• 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: health professional,user faci
• Reporter Occupation: Nurse
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 01/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/31/2017
• Supplement Dates Manufacturer Received: 10/31/2017
• Supplement Dates FDA Received: 01/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention