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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTERSCOPE, INC ENDOROTOR; ENDOSCOPIC MORCELLATOR

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INTERSCOPE, INC ENDOROTOR; ENDOSCOPIC MORCELLATOR Back to Search Results
Model Number 6.0-EPR-EGD
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Perforation (2001)
Event Date 02/10/2022
Event Type  Injury  
Event Description
The treating physician requested endorotor catheters to assist in the treatment of a scarred gastric lesion measuring approximately 4cm x 3cm at the axial/longitudinal axis respectively.A previous procedure was attempted to resect the lesion, but the gi physician could not access the lesion due to anatomical positioning of the lesion.The gi physician then coordinated with a bariatric surgeon to perform a hybrid procedure later.The hybrid procedure had two objectives: provide traction to the gastric wall to facilitate positioning for the endoscopic treatment.In the event the endorotor procedure was unsuccessful the surgeon was available and ready to surgically resect the site.The patient was prepped and draped in accordance with general surgery.Three ports were created into the patient's peritoneal cavity including two instrument ports and camera port.Using standard laparoscopic technique, insufflating the surgical site the surgeon dissected connective tissues until the inferior/anterior gastric wall was exposed.The surgeon then provided traction to the gastric wall from the peritoneal space allowing the gi physician to access the site.The physician treated the area using the endorotor catheter to remove the target scarred area.The physician performed the procedure using 200mmhg of suction pressure within the recommended range for endorotor catheters.After the physician was halfway through the procedure, he noted the depth of resection and so vacuum pressure was adjusted to 1 o0mmhg until 90% of the 4cm x 3cm site was resected.Effective technique was noted by the team during the first 7 minutes of resection, but the physician noted the vacuum level was insufficient to remove the remaining 10% of the target site.The physician then had the team increase the vacuum level back to 200mmhg and completed the remaining resection.It was noted by the lnterscope team that the gi physician made a repeated pass over a previously resected area during the last 2 minutes of the endoscopic resection.The physician investigated the resection and identified a 3mm perforation of the gastric wall.The surgeon, already in position, performed additional dissection to identify the perforation from the surgical field.Once identified the surgeon in coordination with the gi physician decided that although endoscopic management would be sufficient a significantly more secure closure could be performed by the surgeon.The surgeon performed a closure using monocryl filament sutures taking approximately 15 minutes to complete.The patient was discharged the same day without further sequelae.The lnterscope team followed up on the patient status 3 days later and the patient continued to perform well.
 
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Brand Name
ENDOROTOR
Type of Device
ENDOSCOPIC MORCELLATOR
Manufacturer (Section D)
INTERSCOPE, INC
200 commerce drive floor 2
northbridge MA 01534
Manufacturer (Section G)
INTERSCOPE, INC
200 commerce drive floor 2
northbridge MA 01534
Manufacturer Contact
jeffery ryan
200 commerce drive floor 2
northbridge, MA 01534
8774207299
MDR Report Key13804535
MDR Text Key287888971
Report Number3011697028-2022-00019
Device Sequence Number1
Product Code PTE
UDI-Device Identifier00854172008117
UDI-Public(01)00854172008117(17)230510(10)2105048
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 03/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date06/15/2023
Device Model Number6.0-EPR-EGD
Device Catalogue Number6.0-EPR-EGD
Device Lot Number21054B
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/18/2022
Was Device Evaluated by Manufacturer? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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