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

Catalog Number	6700313500
Medical Device Problem Codes	Output above Specifications (1432); Intermittent Energy Output (4025)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported the device energy was out of tolerance during a procedure, a condition which may pose the risk of insufficient coagulation and increased bleeding.The procedure was completed successfully with no surgical delay.No medical intervention or adverse consequences were reported.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.
Additional Manufacturer Narrative
On 9/19/2025, stryker instruments discontinued the practice of filing mdrs for complaints related to intermittent energy output or out of tolerance 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.
Event or Problem Description
No new information.

• 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: 21900499
• Report Number: 3015967359-2025-00951
• Device Sequence Number: 18341611
• Product Code: GEI
• UDI-Device Identifier: 07613327303889
• UDI-Public: (01)07613327303889
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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,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: 04/17/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2025
• Supplement Date Received by Manufacturer: 08/21/2025; 09/19/2025
• Initial Report FDA Received Date: 04/24/2025
• Supplement Report FDA Received Date: 08/22/2025; 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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