MAUDE Adverse Event Report: COVIDIEN MEDICAL PRODUCTS SURGISTAT; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	VLSURGGEN
Medical Device Problem Code	Inaccurate Delivery (2339)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the device had return electrode monitor(rem) testing failed by decrease resistance to alarm.
Additional Manufacturer Narrative
Evaluation summary: one device was received as a service request and a visual inspection and functional test were performed.The device as received met the specifications and passed functional / visual inspection testing.Inspection of the device resulted in finding no fault.The reported condition was not confirmed.According to the technician, "issue not confirmed for nem fails decrease resistance until alarm.All nem readings are within specifications as received.The reported issue could not be confirmed or duplicated through testing and troubleshooting.The unit meets all specifications." the investigation found the device to function normally and within specifications.The unit was subjected to full factory testing / calibration.It passed all tests with no problems or issues found.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SURGISTAT
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MEDICAL PRODUCTS; building 10- no 789 puxing roa; shanghai 20111 4; CN 201114
• MDR Report Key: 8803562
• Report Number: 3006451981-2019-00149
• Device Sequence Number: 18912325
• Product Code: GEI
• UDI-Device Identifier: 10884521517417
• UDI-Public: 10884521517417
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K001955
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2019

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: VLSURGGEN
• Device Catalogue Number: VLSURGGEN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2019
• Initial Date Received by Manufacturer: 07/01/2019
• Supplement Date Received by Manufacturer: 09/17/2019
• Initial Report FDA Received Date: 07/18/2019
• Supplement Report FDA Received Date: 10/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1