MAUDE Adverse Event Report: INTERSCOPE, INC. ENDOROTOR® 3.2MM POWERED ENDOSCOPIC DEBRIDEMENT CATHETER - GASTROSCOPE OLYMPUS/P; ENDOROTOR® 3.2MM PED CATHETER GASTRO

Model Number	3.2-PED-EGD-OP
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pancreatitis (4481)
Date of Event	11/03/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The endorotor was not returned for investigation.The source of the bleeding was not confirmed, therefore no root cause can be determined.Lhr was reviewed and found no process deviations nor nonconformances.There are no other complaints related this failure mode in this lot.
Event or Problem Description
It was reported that on (b)(6).2023 a pancreatic necrosectomy was performed on a patient.This was the patient's 3rd debridement using the endorotor device.The physician stated that once the therapeutic scope was in the necrotic cavity, the endorotor was prepped.No other conventional instruments were used prior to the use of the endorotor catheter.After about 15-20 minutes of debridement using the endorotor catheter, the physician immediately recognized significant bleed.The catheter was quickly removed, and the patient's bleeding was tended to.The patient did not require treatment to control the bleeding and the source of the bleeding was not identified.The bleeding continued for about 40 minutes and then subsided.After the scope was removed, the patient was transported to the intensive care unit.The physician stated there were no noticeable vessels and/or visible risks during the debridement.The physician added that the patient did not have any pancreas left and he and his team were aware that there could be vessels in the necrotic cavity.The following morning, the physician followed up and stated that the patient was stable.It is suspected that the bleeding stemmed from a "small branch of splenic vessels, probably vein; however, there was no known pseudoaneurysm on imaging available".Additional information was obtained on (b)(6).2023, where the physician stated that the patient remained stable, and no further bleeding has been noted.The event did not require any treatment; however, it did require the patient to be admitted.The physician conveyed that the endorotor was not a factor in the bleeding and that the event was related to the patients' comorbidities.There was no device failure reported and no additional intervention was required.

• Brand Name: ENDOROTOR® 3.2MM POWERED ENDOSCOPIC DEBRIDEMENT CATHETER - GASTROSCOPE OLYMPUS/P
• Common Device Name: ENDOROTOR® 3.2MM PED CATHETER GASTRO
• Manufacturer (Section D): INTERSCOPE, INC.; 200 commerce drive; northbridge MA 01534
• Manufacturer (Section G): INTERSCOPE, INC; 200 commerce drive; norrthbridge 01534
• Manufacturer Contact: jeffery ryan ; 200 commerce drive; northbridge, MA 01534
• MDR Report Key: 18245773
• Report Number: 3011697028-2023-00044
• Device Sequence Number: 7060189
• Product Code: QNE
• UDI-Device Identifier: 00854172008193
• UDI-Public: 00854172008193
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: DEN200016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/29/2023

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: 05/02/2023
• Device Model Number: 3.2-PED-EGD-OP
• Device Lot Number: 230502B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2023
• Initial Report FDA Received Date: 12/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2023
• Is the Device Labeled for Single Use? (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: Hospitalization
• Patient Sex: Unknown