MAUDE Adverse Event Report: RESHAPE LIFESCIENCES GASTROINTESTINAL BOUNDARY IDENTIFIER (GIBI HD) 36FR; INTRODUCTION/DRAINAGE CATHETER

Model Number	B-2036
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the surgeon experienced difficulties with retrieving the gastrointestinal boundary identifier (gibi) hd gastric tube during surgery.During the primary laparoscopic gastric bypass, the gibi gastric tube size 36 fr was utilized as a guide to size the stomach pouch and roux limb.Following the creation of the stomach pouch, the tube was advanced into the jejunum and was used as a sizing guide to create the gastrojejunal anastomosis.The tube's soft tip and balloon were positioned distally to the anatomosis site before suture was made.Upon the completion of the gastrojejunal anastomosis, the surgeon attempted to retrieve the gastric tube by pulling it proximally; however, the tube had difficulty passing through the sutured gastrojejunal anastomosis.The suture was loosened to allow the tube retrieval.The site was resutured.Endoscopy was used to identify and repair any leakage.Due to the difficulty of tube retrieval, the surgery was extended.There was no report of injury to the patient or device malfunction.
Additional Manufacturer Narrative
The complaint is pending on the completion of the investigation.Once evaluation is completed, a supplemental report will be submitted.
Additional Manufacturer Narrative
The device was not available to be examined.As a result the investigation involved a review of manufacturing records and risk files.The device was manufactured to specification.The risk file was reviewed and found that the placement of staples/stitches around the device could make it difficult to remove the catheter, thus a corrective action has been initiated (capa 2036).The investigation for this complaint includes the capa 2036 investigation and is considered a single complaint (for reporting purpose).This corrective action will identify the root cause and take the necessary actions to prevent recurrence of the event(s) reported in this complaint.The lot history record was reviewed and no discrepancies or non-conformance's recorded.Product was manufactured according to specification.Unable to determine root cause.The investigation findings do not lead to a clear conclusion about the cause of the reported adverse events.

• Brand Name: GASTROINTESTINAL BOUNDARY IDENTIFIER (GIBI HD) 36FR
• 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: 15720548
• Report Number: 3013508647-2022-00221
• Device Sequence Number: 11495691
• Product Code: KNT
• UDI-Device Identifier: 00850007764227
• UDI-Public: (01)00850007764227(10)783371(11)220518(17)240518
• 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: 05/18/2024
• Device Model Number: B-2036
• Device Catalogue Number: B-2036
• Device Lot Number: 783371
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2022
• Supplement Date Received by Manufacturer: 12/16/2022
• Initial Report FDA Received Date: 11/03/2022
• Supplement Report FDA Received Date: 01/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2022
• 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: Unknown