MAUDE Adverse Event Report: RESHAPE LIFESCIENCES GASTROINTESTINAL BOUNDARY IDENTIFIER (GIBI HD); INTRODUCTION/DRAINAGE CATHETER

Model Number	GIBI HD, 32FR
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
While performing an irrigation/leak test using a luer lock syringe, a leak was observed at the syringe/christmas junction.While the crna was attempting to diagnose the leak by manually adjusting the junction, the connector on lumen a seperated from the lumen.The gibi was removed from the patient and the leak performed using another device (visigi or og tube).
Additional Manufacturer Narrative
Investigation findings pending results of investigation.
Additional Manufacturer Narrative
An investigation of the reported event confirmed that the adapter could be separated from the adapter tubing but only under conditions not used in a clinical setting.Because a pull test of the device is not applicable once the adapter separates from the tubing, the only remaining test was to determine if the tubing and adapter meet dimension specifications.The device was manufactured to specification and this was confirmed by a bench test which measured the critical device dimensions relevant to the event.No trending information is available, as this is only the second complaint received for this device and first for this complaint category.This event is the risk file rfmea0002 rev d (dfmea d-93-d98), and no corrective or preventive actions are required at this time.Unable to determine root cause.The investigation findings do not lead to a clear conclusion about the cause of the reported event.

• Brand Name: GASTROINTESTINAL BOUNDARY IDENTIFIER (GIBI HD)
• Common Device Name: INTRODUCTION/DRAINAGE CATHETER
• Manufacturer (Section D): RESHAPE LIFESCIENCES; 1001 calle amanecer; san clemente CA 92673
• Manufacturer Contact: toan hoang ; 1001 calle amanecer; san clemente, CA 92673 ; 9492764349
• MDR Report Key: 15686741
• Report Number: 3013508647-2022-00213
• Device Sequence Number: 7359837
• Product Code: KNT
• UDI-Device Identifier: 00850007764210
• UDI-Public: (01)00850007764210(10)770965(11)220503(17)240503
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K221898
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2023

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 Expiration Date: 05/03/2024
• Device Model Number: GIBI HD, 32FR
• Device Catalogue Number: B-2032
• Device Lot Number: 770965
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2022
• Supplement Date Received by Manufacturer: 01/05/2023
• Initial Report FDA Received Date: 10/27/2022
• Supplement Report FDA Received Date: 01/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male