Model Number A-SP3-03K |
Device Problem
Deflation Problem (1149)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/11/2023 |
Event Type
malfunction
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Event Description
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The doctor wanted to fill the balloon with liquid, but only a small part of liquid went into the balloon, the bigger part went into the patient's stomach.
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Manufacturer Narrative
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To date, spatz fgia inc.Has not received the product for evaluation, therefore no analysis or testing has been done.A review of the device labeling notes the following: each patient must be monitored closely during the entire term of treatment in order to detect the development of possible complications.Each patient should be instructed to report to physicians immediately regarding any and all change of symptoms.Symptoms of deflation, gastrointestinal obstruction, ulceration and other complications which might occur should be reviewed with patient, and patients should be advised to contact his/her physician immediately upon the onset of such symptoms.Patients reporting loss of satiety, increased hunger and/or weight gain should be examined radiographically and/or endoscopically, as this is indicative of a balloon deflation.It is necessary to replace a balloon which has spontaneously deflated.Complications- possible complications of the use of the spatz3 adjustable balloon system include: balloon deflation and subsequent replacement.
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Manufacturer Narrative
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The device was returned to spatz fgia inc.For analysis on 11/26/2023 and an evaluation was completed.The testing revealed a linear cut at the inflation tube area that probably was caused during the implantation procedure.A review of the device labeling notes the following: each patient must be monitored closely during the entire term of treatment in order to detect the development of possible complications.Each patient should be instructed to report to physicians immediately regarding any and all change of symptoms.Symptoms of deflation, gastrointestinal obstruction, ulceration and other complications which might occur should be reviewed with patient, and patients should be advised to contact his/her physician immediately upon the onset of such symptoms.Patients reporting loss of satiety, increased hunger and/or weight gain should be examined radiographically and/or endoscopically, as this is indicative of a balloon deflation.It is necessary to replace a balloon which has spontaneously deflated.Complications- possible complications of the use of the spatz3 adjustable balloon system include: balloon deflation and subsequent replacement.
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Event Description
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The doctor wanted to fill the balloon with liquid, but only a small part of liquid went into the balloon, the bigger part went into the patient's stomach.
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Search Alerts/Recalls
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