MAUDE Adverse Event Report: MOBILE INSTRUMENT SERVICE AND REPAIR, INC INSULCAN; COAGULATOR, LAPAROSCOPIC, AND ACCESSORIES

Model Number 9400-02

Device Problems Break (1069); Thermal Decomposition of Device (1071); Melted (1385); Malposition of Device (2616)

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

Event Date 09/22/2014

Event Type  Other  

Event Description

These devices are to check the insulation on laparoscopic instruments.Five (5) have failed in the last two weeks.The wiring inside the device coming from the power connector (12 volt dc)to the pc board and battery have melted and burned.
=
manufacturer response for insulation tester, insulcan (per site reporter).
=
none yet.

• Brand Name: INSULCAN
• Type of Device: COAGULATOR, LAPAROSCOPIC, AND ACCESSORIES
• Manufacturer (Section D): MOBILE INSTRUMENT SERVICE AND REPAIR, INC; 333 water ave; bellefountaine OH 43311
• MDR Report Key: 4154843
• MDR Text Key: 15322344
• Report Number: 4154843
• Device Sequence Number: 1
• Product Code: HFG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/24/2014

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: Invalid Data
• Device Model Number: 9400-02
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/24/2014
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/09/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/24/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Other