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

Model Number 52969

Device Problems Device Operates Differently Than Expected (2913); Temperature Problem (3022)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/24/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Review of and service repair logs.Per repair authorization form: " no heat no cautery at blend of 40." (b)(4).

Manufacturer Narrative

Ref.E-complaint (b)(4).Please find attached the leep 1000 final mdr submission package , regarding all initial mdr's ,and retro review initial mdr's filed for reports of intermittent function during use.The documents included in this package are as follows: · leep system investigation summary · leep 1000 tech bulletin cover letter · tech service bulletin 12151 · project #1676 - leep system 1000 root cause.This concludes coopersurgical' s root cause investigation.Coopersurgical, inc.Will continue to monitor the complaint condition for tending and safety.

Event Description

Review of and service repair logs.Per repair authorization form: " no heat no cautery at blend of 40." ref repair order log 82137.Ref.E-complaint-(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: 5705796
• MDR Text Key: 48053992
• Report Number: 1216677-2016-00043
• Device Sequence Number: 1
• Product Code: HGI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 11/10/2016

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: 52969
• Device Catalogue Number: 52969
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/26/2016
• Initial Date FDA Received: 06/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2009
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other