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Model Number ESS-G02-SX1 |
Device Problems
Material Perforation (2205); Mechanical Jam (2983)
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Patient Problem
Laceration(s) of Esophagus (2398)
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Event Date 12/12/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Initial medwatch submitted to the fda on 15/sep/2023.A review of the device labeling notes the following: the current overstitch¿ endoscopic suturing system (ess) instructions for use (ifu) addressed the known and potential event of esophageal laceration as follows: the apollo endosurgery overstitch¿ endoscopic suture system (ess) is intended for endoscopic placement of suture(s) and approximation of soft tissue.Contraindications include those specific to use of an endoscopic suturing system, and any endoscopic procedure, which may include, but not limited to, the following: · this system is not for use where endoscopic techniques are contraindicated.· this system is not for use with malignant tissue.Adverse events possible complications that may result from using the endoscopic suturing system include, but may not be limited to: · pharyngitis / sore throat · nausea and / or vomiting · abdominal pain and / or bloating · hemorrhage · hematoma · conversion to laparoscopic or open procedure · stricture · infection / sepsis · pharyngeal, colonic and/or esophageal perforation · esophageal, colonic and/or pharyngeal laceration · intra-abdominal (hollow or solid) visceral injury · aspiration · wound dehiscence · acute inflammatory tissue reaction · death note: any serious incident that has occurred in relation to the device should be reported to apollo endosurgery (see contact information at the end of this document) and any appropriate government entity.Additional information: the investigator determined that a device history record (dhr) review is required for this complaint due to the complaint being mdr reportable.There are no other complaints against this lot number (2022051243) and allegation.
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Event Description
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Healthcare professional reported after deploying the cinch and cutting the suture, the needle body could not be closed due to unknown reasons.It caused a patient esophagus laceration when removing it from the endoscope.
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Manufacturer Narrative
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Supplemental medwatch submitted to the fda on 06nov2023.Additional information: the investigator determined that a device history record (dhr) review is required for this complaint due to the complaint being mdr reportable.The subject product met all specifications and requirements in effect at the time of manufacture.There are no other complaints against this lot number (2022051243) and allegation.Device evaluation summary: the device was returned to the apollo device analysis laboratory on 09/oct/2023.One needle driver and anchor exchange were returned for investigation.Prior to decontamination, engineering functionally tested the device.The handle opens and closes as intended; however, due to the bent needle body tip, the tip does not go into the endcap.Under microscopic analysis, the needle body tip is severely bent.The complaint has been verified as the needle body is bent; therefore, will prevent it from closing.Lab analysis was able to replicate the reported event of "overstitch-difficulty closing needle body", as the needle body is severely bent.The user effect of "overstitch-difficulty closing needle body" is known and labeled possible adverse event.
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Search Alerts/Recalls
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