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

Catalog Number	6700313500
Medical Device Problem Code	Output above Specifications (1432)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A manufacturer sales representative reported the device was overdelivering energy during use in a procedure at the user facility, a condition which may pose the risk of tissue damage.The procedure was completed successfully.There was no surgical delay, no medical intervention, and no adverse consequences reported in this event.
Event or Problem Description
A manufacturer sales representative reported the device was over delivering energy during use in a procedure at the user facility, a condition which may pose the risk of tissue damage.The procedure was completed successfully.There was no surgical delay, no medical intervention, and no adverse consequences reported in this event.
Additional Manufacturer Narrative
Follow-up report submitted to document device evaluation results.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
On 9/19/2025 stryker instruments discontinued the practice of filing mdrs for complaints related to overdelivering energy for devices registered under gei product code in according to fda's "final guidance on medical device reporting for manufacturers" section 2.15.This malfunction has not caused or contributed to any serious injuries or deaths in at least two years.No new mdrs will be filed for this malfunction and corrected supplemental mdrs will be submitted if necessary for any events pending device investigation.

• 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
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: kelsey barla ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 20396347
• Report Number: 3015967359-2024-01876
• Device Sequence Number: 3579491
• Product Code: GEI
• UDI-Device Identifier: 07613327303889
• UDI-Public: (01)07613327303889
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 09/19/2025

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: 10/03/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/12/2024
• Supplement Date Received by Manufacturer: 04/08/2025; 09/19/2025
• Initial Report FDA Received Date: 10/08/2024
• Supplement Report FDA Received Date: 04/09/2025; 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown