MAUDE Adverse Event Report: COOPERSURGICAL, INC. LEEP SYSTEM

Model Number 52969

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

Patient Problems Pain (1994); Partial thickness (Second Degree) Burn (2694)

Event Date 05/06/2016

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical inc.Is currently investigating the reported complaint condition.The device involved in the complaint has not yet been returned by the customer for evaluation.Once the investigation is completed a follow-up report will be filed.(b)(4).

Event Description

Summary surgery/procedure event (b)(6).Incident description: leep procedure, grounding pad located on upper left thigh, plugged into machine, when the physician was using cutting feature at 46w power there were no issues, and then unit was switched over to cautery tool, unit power was set at 36w, halfway through the procedure when using ball to cauterize, patient jumped and claimed of pain, insulated speculum in place, dr withdrew cauterize tool and observed 2 burned spots on sides of procedure area.Procedure was immediately halted and different methods were used to treat patient nature of injury - burn.Location of injury on body - vagina.Harm - temporary, intervention needed.(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 #(b)(4)- 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

Summarysurgery/procedure event (b)(4).Incident description: leep procedure, grounding pad located on upper left thigh, plugged into machine, when the physician was using cutting feature at 46w power there were no issues, and then unit was switched over to cautery tool, unit power was set at 36w, halfway through the procedure when using ball to cauterize, patient jumped and claimed of pain, insulated speculum in place, dr withdrew cauterize tool and observed 2 burned spots on sides of procedure area.Procedure was immediately halted and different methods were used to treat patient.Nature of injury - burn, location of injury on body - vagina, harm - temporary, intervention needed.Reference e-complaint (b)(4).

• Brand Name: LEEP SYSTEM
• Type of Device: LEEP SYSTEM
• 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 coporate drive; trumbull, CT 06611 ; 2036015200
• MDR Report Key: 5736723
• MDR Text Key: 48733319
• Report Number: 1216677-2016-00045
• 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: Inspection
• Type of Report: Initial,Followup
• Report Date: 11/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2016
• 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: 08/25/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/09/2005
• 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): Other; Required Intervention