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

Model Number	ACT1520
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/11/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.If the sample is received or if additional information pertinent to the incident is obtained a follow-up report will be submitted.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer reported that the electrode was set according to the manual.It was activated but the unit would not start and an ¿impedance over¿ error was displayed repeatedly.The procedure was cancelled.There was no harm to the patient.
Additional Manufacturer Narrative
One act1520 was received for evaluation.A review of the lot number reported indicates that the product was within the assigned expiration date at the time of the reported incident.Visual inspection found no defects.The customer reported that the temperature was not stable.The reported condition was confirmed.The water circulated normally through the sample but the sample did not read the temperature properly.Evaluation found the thermocouple solder joint was broken.This is a manufacturing related failure.Corrective action was implemented subsequent to the manufacture of the incident device.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer reported the needle was set according to the manual.It was activated but the unit would not start and ¿impedance over¿ was shown on the display repeatedly.The procedure was cancelled.There was no harm to the patient.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• 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: 6554333
• Report Number: 1717344-2017-05305
• Device Sequence Number: 557827
• Product Code: GEI
• UDI-Device Identifier: 10884524001180
• UDI-Public: 10884524001180
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K053290
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/01/2019
• Device Model Number: ACT1520
• Device Catalogue Number: ACT1520
• Device Lot Number: 62940056X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2017
• Initial Date Received by Manufacturer: 04/11/2017
• Supplement Date Received by Manufacturer: 07/18/2017; 07/18/2017
• Initial Report FDA Received Date: 05/09/2017
• Supplement Report FDA Received Date: 08/14/2017; 09/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other