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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC. OVERSTITCH ENDOSCOPIC SUTURING SYSTEM
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APOLLO ENDOSURGERY, INC. OVERSTITCH ENDOSCOPIC SUTURING SYSTEM Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Abdominal Pain (1685); Nausea (1970); Vomiting (2144)
Event Type  malfunction  
Event Description
Patient symptoms vomiting, nausea and pain.From a literature review.
 
Manufacturer Narrative
Initial medwatch submitted to the fda on 22/oct/2021.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 "overstitch-clinical outcome device related" as follows: possible complications that may result from using the endoscopic suturing system include, but may not be limited to: nausea and / or vomiting, abdominal pain and / or bloating.Additional information: the device has not been returned for analysis.The investigator is waiting until the lot number of the device is known to determine whether a device history record (dhr) review is or is not required for this complaint.
 
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Brand Name
OVERSTITCH ENDOSCOPIC SUTURING SYSTEM
Type of Device
ENDOSCOPIC SUTURING SYSTEM
Manufacturer (Section D)
APOLLO ENDOSURGERY, INC.
1120 s. capital of texas hwy
bldg 1, ste. 300
austin TX
MDR Report Key12682360
MDR Text Key282214826
Report Number3006722112-2021-00100
Device Sequence Number1
Product Code OCW
Combination Product (y/n)N
PMA/PMN Number
K081853
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,litera
Type of Report Initial
Report Date 09/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received09/28/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age52 YR
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