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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: APOLLO ENDOSURGERY OVERSTITCH ENDOSCOPIC SUTURE SYSTEM; ENDOSCOPIC TISSUE APPROXIMATION DEVICE
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APOLLO ENDOSURGERY OVERSTITCH ENDOSCOPIC SUTURE SYSTEM; ENDOSCOPIC TISSUE APPROXIMATION DEVICE Back to Search Results
Model Number ESS-G02-160
Device Problems Break (1069); Device-Device Incompatibility (2919); Difficult to Open or Close (2921); Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/11/2023
Event Type  malfunction  
Manufacturer Narrative
Block h6 idmf code a051104 difficult to open or close captures the reportable event of needle shaft unable to close.
 
Event Description
It was reported to boston scientific corporation that an overstitch endoscopic suture system was used during a stent placement on (b)(6) 2023 to fix an esophageal stricture.During the setup of the device, it was noticed that the handle felt gritty.Additionally, they physician said the anchor and needle body looked different.Then upon activation of the device during set up the handle itself broke.The anchor and needle body would not shuttle back and forth.The device was not used in the patient.Another of the same device was used to complete the procedure.
 
Manufacturer Narrative
Block h6: idmf code a051104 difficult to open or close captures the reportable event of needle shaft unable to close.During the product analysis one needle driver would not retract when the handle was opened, and no more failures or damages were noted in the device.It was confirmed this device met specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.A risk review was completed and confirmed that the event of shaft failure to close, anchor exchange failure to pass anchor, needle shaft bent and handle break was defined in the risk documentation and is documented accordingly in the prr.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.For the as reported anchor exchange failure to pass anchor, needle shaft bent and handle break these events cannot be confirmed because there is not an objective evidence or descriptive conditions to confirm the reported event.For this reason, this event is catalogued as no problem detected because the as reported code cannot be confirmed.This investigation is assigned a most probable conclusion code of adverse event related to procedure.This conclusion was selected because during the product analysis one needle driver would not retract when the handle was opened.After visual inspection, a clip was wedged in the endcap which was preventing the retraction of the needle body.The conclusion is acceptable because the adverse event occurred during the procedure and the device had no influence on event.All compiled information on this investigation determines that the most probable cause is: adverse event related to procedure.
 
Event Description
It was reported to boston scientific corporation that an overstitch endoscopic suture system was used during a stent placement on (b)(6) 2023 to fix an esophageal stricture.During the setup of the device, it was noticed that the handle felt gritty.Additionally, they physician said the anchor and needle body looked different.Then upon activation of the device during set up the handle itself broke.The anchor and needle body would not shuttle back and forth.The device was not used in the patient.Another of the same device was used to complete the procedure.
 
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Brand Name
OVERSTITCH ENDOSCOPIC SUTURE SYSTEM
Type of Device
ENDOSCOPIC TISSUE APPROXIMATION DEVICE
Manufacturer (Section D)
APOLLO ENDOSURGERY
1120 s. capital of texas hwy
bldg 1 suite 300
austin TX 78746
Manufacturer (Section G)
VIANT MEDICAL INC
620 watson st sw
grand rapids MI 49504
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key18486588
MDR Text Key333097279
Report Number3005099803-2024-00031
Device Sequence Number1
Product Code OCW
UDI-Device Identifier20811955020661
UDI-Public20811955020661
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K191439
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/29/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/10/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberESS-G02-160
Device Lot Number2023031356
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/06/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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