MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER COOL-TIP; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	ACT1530
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One device was received for evaluation.This device had been used in the treatment or diagnosis of a patient.A review of the lot number reported indicates that the product was within the assigned expiration date at the time of the reported incident.The returned product did not meet specification as received.Visual inspection found no defects.The reported condition was confirmed.The water circulated normally through the device.The device did not read the temperature properly.The needle was removed.The solder joint at the tip of the thermocouple was found to be broken.The investigation identified the root cause of the reported event to be a poor solder joint.Corrective actions have been implemented to mitigate this issue.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, intra-operatively, the generator, pump and tube were properly connected but single electrode did not work at all.In panel, there was no measurement of temperature, current and watt during procedure.They changed for a new product with a different lot number in order to complete the case.There was no injury caused to the patient.Initial evaluation of the incident found that the solder joint at the tip of the thermocouple was found to be broken.

• Brand Name: COOL-TIP
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 7848277
• Report Number: 1717344-2018-01175
• Device Sequence Number: 1468719
• Product Code: GEI
• UDI-Device Identifier: 10884524000947
• UDI-Public: 10884524000947
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K973297
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/05/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/03/2020
• Device Model Number: ACT1530
• Device Catalogue Number: ACT1530
• Device Lot Number: 70310154X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2018
• Initial Report FDA Received Date: 09/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1