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

Model Number 3.2-EPR-COL-OP

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation (2001)

Event Date 07/27/2021

Event Type  Injury  

Event Description

Detailed description of event: the endorotor system was setup according to ifu.The patient was an (b)(6) year old female.Dr.(b)(6), the advanced fellow, performed the entire procedure.Dr.(b)(6) had difficulty maneuvering the colonoscope to the ascending colon to evaluate the polyp so dr.(b)(6) switched from co2 to air (slower absorption) for insufflation.The distal end of the polyp was on the precipice of a fold.There was visible scaring so dr.(b)(6) decided to resect with the endorotor catheter.Dr.(b)(6) performed a submucosal injection with epinephrine.Dr.(b)(6) then began resecting the lesion with endorotor.The suction unit was at 150mmhg and the cutting speed was on low as per recommendations in labeling.Half way through dr.(b)(6) noticed a small opening within the resected area of the mucosa that appear to be contained within the submucosa.Dr.(b)(6) continued the resection of the rest of the lesion without issue.Upon completion, dr.(b)(6) placed a hemostatic clip over the opening.Following the procedure, the patient underwent x-ray and free air in the abdomen was discovered.They admitted the patient for observation.The patient had no deterioration in health and recovered well.The patient was released the following day in good health.On follow-up, dr.(b)(6) indicated that it was most likely a micro-perforation potentially connected to use of air for insufflation while resecting.

• 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 Key: 13804522
• MDR Text Key: 287524547
• Report Number: 3011697028-2021-00017
• Device Sequence Number: 1
• Product Code: PTE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• 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 Model Number: 3.2-EPR-COL-OP
• Device Catalogue Number: 3.2-EPR-COL-OP
• Device Lot Number: UKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/04/2021
• Initial Date FDA Received: 03/18/2022
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other