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

Model Number 6700-343-500

Device Problems Intermittent Loss of Power (4016); Intermittent Energy Output (4025)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/15/2021

Event Type  malfunction  

Event Description

The user facility reported the device would shut down during use and sometimes could not be powered back on, a condition which may pose the risk of insufficient coagulation and increased bleeding.The procedure was completed successfully.There was no clinically significant delay, no medical intervention, and no adverse consequences.

Manufacturer Narrative

Follow-up report submitted to document device evaluation results.

Event Description

The user facility reported the device would shut down during use and sometimes could not be powered back on, a condition which may pose the risk of insufficient coagulation and increased bleeding.The procedure was completed successfully.There was no clinically significant delay, no medical intervention, and no adverse consequences.

• Brand Name: BIPOLAR GENERATOR
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: zach baker ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 13392826
• MDR Text Key: 284691265
• Report Number: 3015967359-2022-00277
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 07613327303889
• UDI-Public: 07613327303889
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050364
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/14/2022

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
• Device Operator: Health Professional
• Device Model Number: 6700-343-500
• Device Catalogue Number: 6700313500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/06/2022
• Initial Date FDA Received: 01/31/2022
• Supplement Dates Manufacturer Received: 04/13/2022
• Supplement Dates FDA Received: 04/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1