MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP BIPOLAR GENERATOR; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	6700-343-500
Medical Device Problem Code	Intermittent Energy Output (4025)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during testing by the manufacturer sales representative at the user facility, the device had intermittent energy output, a condition which may pose the risk of insufficient coagulation and increased bleeding.There were no adverse consequences related to this event.
Event or Problem Description
It was reported that during testing by the manufacturer sales representative at the user facility, the device had intermittent energy output, a condition which may pose the risk of insufficient coagulation and increased bleeding.There were no adverse consequences related to this event.
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-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• MDR Report Key: 11483413
• Report Number: 3015967359-2021-00160
• Device Sequence Number: 3829515
• Product Code: GEI
• UDI-Device Identifier: 07613327303889
• UDI-Public: 07613327303889
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K050364
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2021

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: Other
• Device Model Number: 6700-343-500
• Device Catalogue Number: 6700313500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2021
• Initial Date Received by Manufacturer: 02/15/2021
• Supplement Date Received by Manufacturer: 06/21/2021
• Initial Report FDA Received Date: 03/15/2021
• Supplement Report FDA Received Date: 06/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1