MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO BIPOLAR GENERATOR; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	6700313500
Medical Device Problem Code	Energy Output Problem (1431)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Failure analysis is in progress; additional information will be submitted once the quality investigation is completed.
Event or Problem Description
The user facility reported that the device had intermittent output during a procedure, a condition in which the device may over deliver or under deliver energy.The procedure was completed successfully.There was no delay, no medical intervention, and no adverse consequences.
Event or Problem Description
The user facility reported that the device had intermittent output during a procedure, a condition in which the device may overdeliver or underdeliver energy.The procedure was completed successfully.There was no delay, no medical intervention, and no adverse consequences.
Additional Manufacturer Narrative
Follow-up report submitted to document device evaluation results.

• Brand Name: BIPOLAR GENERATOR
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8556848
• Report Number: 0001811755-2019-01530
• Device Sequence Number: 2292739
• Product Code: GEI
• UDI-Device Identifier: 07613327303889
• UDI-Public: 07613327303889
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K050364
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2019

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 Catalogue Number: 6700313500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2019
• Initial Date Received by Manufacturer: 04/03/2019
• Supplement Date Received by Manufacturer: 06/11/2019
• Initial Report FDA Received Date: 04/26/2019
• Supplement Report FDA Received Date: 06/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1