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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESHAPE LIFESCIENCES LAP BAND SYSTEM CALIBRATION TUBE; GASTRIC CALIBRATION TUBE
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RESHAPE LIFESCIENCES LAP BAND SYSTEM CALIBRATION TUBE; GASTRIC CALIBRATION TUBE Back to Search Results
Model Number B-2017
Device Problems Inflation Problem (1310); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
Patient Problem Perforation of Esophagus (2399)
Event Date 12/08/2020
Event Type  Injury  
Event Description
Serious esophageal dissection incident that occurred with the apollo b- 2017 calibration tube during a sleeve gastrectomy.This follows confusion of the tips when using the device, yet with trained personnel.The tubing is difficult to identify when the probe is inserted into the patient's esophagus.To perform the leak test, the balloon was mistakenly inflated with methylene blue (120ml) through the tip of the "balloon" conduit.This caused dilaceration of the thoracic esophagus with pneumothorax, pleural effusion, having led the patient to intensive care, the patient's life-threatening prognosis was engaged.The patient underwent an esophageal prosthesis on (b)(6) 2020, pleural drainage, she did not need to be reintubated.
 
Manufacturer Narrative
Additional codes added in section h regarding type of investigation, investigation findings and investigation conclusion.
 
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Brand Name
LAP BAND SYSTEM CALIBRATION TUBE
Type of Device
GASTRIC CALIBRATION TUBE
Manufacturer (Section D)
RESHAPE LIFESCIENCES
1001 calle amanecer
san clemente CA 92673
MDR Report Key11385934
MDR Text Key233780713
Report Number3013508647-2021-00001
Device Sequence Number1
Product Code LTI
Combination Product (y/n)N
PMA/PMN Number
P000008
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 03/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberB-2017
Device Catalogue NumberB-2017
Was Device Available for Evaluation? No
Date Manufacturer Received12/11/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Required Intervention;
Patient Age34 YR
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