MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER EMPRINT; SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES

Model Number	CAAL9150L
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: health professional (hpro).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a procedure, the probe clip caught on the trocar when it was being removed from the patient.The white clip broke in half and was then removed from the body.There was no patient injury.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
This report is based on information provided by the global complaint handling system.The product was not returned, however, a picture was provided by the customer for analysis.The picture showed the clip was broken.The customer reported the probe clip caught on the trocar when it was being removed from the patient.The reported condition was confirmed.The investigation of the picture found the clip was broken.Medtronic could not determine why the clip broke.The investigation could not determine the root cause of the customer's report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: EMPRINT
• Common Device Name: SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 7824683
• Report Number: 1717344-2018-01141
• Device Sequence Number: 1143057
• Product Code: NEY
• UDI-Device Identifier: 10884521703322
• UDI-Public: 10884521703322
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K171358
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/30/2018

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 Model Number: CAAL9150L
• Device Catalogue Number: CAAL9150L
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/10/2018
• Supplement Date Received by Manufacturer: 08/24/2018; 11/07/2018
• Initial Report FDA Received Date: 08/28/2018
• Supplement Report FDA Received Date: 09/14/2018; 11/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR