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

Model Number	ACT2020
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: two dgphp were received for evaluation.The act2020 was not returned for evaluation.The returned product did not meet specification as received.Visual inspection found both pads are missing the term covers.One of the pads has the wire disengaged from the termination.The reported condition was confirmed.The investigation found both pads are missing the term covers.One of the pads has the wire disengaged from the termination.Manufacturing engineer confirmed the complaint product returned did not meet acceptance criteria with the finish products containing no termination cover.Also, one of the two pads returned with cable and crimp removed from the pad.No formal investigation actions are being taken.In the current manufacturing process for this product, there are redundant inspections for the missing termination cover or miss termination of the cable at the term cover application and pad continuity test step and then again at the packaging step.The investigation identified the root cause of the reported event to be manufacturing error.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, prior to use, the cord of the pad was disengaged.Replaced with new similar device and it worked fine.There was no patient involved.

• 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: 9243913
• Report Number: 1717344-2019-01423
• Device Sequence Number: 305988
• Product Code: GEI
• UDI-Device Identifier: 10884524001210
• UDI-Public: 10884524001210
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K973297
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/28/2019

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 Model Number: ACT2020
• Device Catalogue Number: ACT2020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2019
• Initial Report FDA Received Date: 10/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1