MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. GI 4000 ELECTROSURGICAL GENERATOR

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Perforation (2001); Insufficient Information (4580)

Event Date 12/14/2021

Event Type  malfunction  

Manufacturer Narrative

The device subject of the event will be returned to the supplier for evaluation.A follow-up report will be submitted when additional information becomes available.

Event Description

The user facility reported a perforation was detected during a procedure which included use of their gi4000 esu.The perforation did not require additional treatment and the patient was reported to be stable.

Manufacturer Narrative

The gi4000 esu unit subject of the event was returned to the supplier for evaluation, and the device was found to be operating according to specifications.A steris account manager will be conducting in-service training with user facility personnel during the first week of (b)(6) 2022 regarding the proper use and operation of the gi4000 esu.No additional issues have been reported.

• Brand Name: GI 4000 ELECTROSURGICAL GENERATOR
• Type of Device: ELECTROSURGICAL GENERATOR
• 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: 13238266
• MDR Text Key: 287389894
• Report Number: 1528319-2022-00002
• Device Sequence Number: 1
• Product Code: GEI
• 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: 01/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2021
• 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