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

Model Number	6.0-EPR-EGD
Health Effect - Clinical Code	Perforation (2001)
Date of Event	02/10/2022
Type of Reportable Event	Serious Injury
Event or Problem 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.

• Brand Name: ENDOROTOR
• Common Device Name: 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 Key: 13804535
• Report Number: 3011697028-2022-00019
• Device Sequence Number: 17724094
• Product Code: PTE
• UDI-Device Identifier: 00854172008117
• UDI-Public: (01)00854172008117(17)230510(10)2105048
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 06/15/2023
• Device Model Number: 6.0-EPR-EGD
• Device Catalogue Number: 6.0-EPR-EGD
• Device Lot Number: 21054B
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown