MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. GI4000 ELECTROSURGERY UNIT

Model Number G1110001

Device Problems Use of Device Problem (1670); Insufficient Information (3190)

Patient Problem Skin Discoloration (2074)

Event Date 06/21/2023

Event Type  malfunction  

Manufacturer Narrative

Steris endoscopy has requested that the gi4000 esu be returned to the repair facility, cintron, for evaluation.Investigation of this event is currently in process.A follow-up mdr will be submitted when additional information becomes available.

Event Description

The user facility reported that during a patient procedure using argon plasma coagulation (apc), the patient's tissue appeared to be a different color than expected.The procedure was successfully completed using clips which resulted in a procedure delay.No report of injury.

Manufacturer Narrative

The gi4000 esu unit subject of the event was returned to the repair facility, cintron, for evaluation.The device was tested and found to be operating according to specifications.The arc smart probe subject of the event was not returned for evaluation.Based on the description of the event and the evaluation results, the root cause could not be determined.The user and maintenance manual for the gi4000 esu gives the following information to the user: "warning: gas embolism and intraluminal gas pressure hazard.The argon gas flow rate should be set to the lowest setting in order to achieve desired effect.The patient should be continually assessed for over insufflation throughout the procedure.Do not point the distal end of apc accessory directly into open vessels or soft tissue.This may result in an argon embolism.Always verify gi4000 esu method/mode and power output settings.Failure to verify settings may result in serious patient injury.Caution: current leakage hazard.The gi4000 should never be used in conjunction with other equipment for which safety against leakage current has not been established."" the instructions for use for the arc smart probe gives the following information to the user: "never activate the argon probe when the open tip is in direct contact with the tissue as this may cause a mild emphysema or embolism and may increase the risk of perforation." a 3-year complaint review indicates this to be an isolated event.No additional issues have been reported.

• Brand Name: GI4000 ELECTROSURGERY UNIT
• Type of Device: GI4000 ELECTROSURGERY UNIT
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley road; mentor OH 44060
• Manufacturer (Section G): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley road; mentor, OH 44060 ; 4403586251
• MDR Report Key: 17350559
• MDR Text Key: 319315868
• Report Number: 1528319-2023-00030
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00724995180256
• UDI-Public: 00724995180256
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: G1110001
• Device Catalogue Number: G1110001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/21/2023
• Initial Date FDA Received: 07/19/2023
• Supplement Dates Manufacturer Received: 06/21/2023
• Supplement Dates FDA Received: 09/29/2023
• 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