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

Model Number	3.2-EPR-COL-OP
Health Effect - Clinical Code	Perforation (2001)
Date of Event	01/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Target area for er resection: transverse colon, 2cm x 0.5cm scarred tissue bed total time for emergency room resection: 15min.Orientation of scar bed to scope: length of scar bed was east to west (3 > 9 o'clock on a face of a clock) physician noted a 'hole' in the colon tissue.Upon going back to 9 o'clock section to continue resecting, it was noted there was a 'hole' at 7-8 o'clock.Emergency room catheter was immediately removed from scope and 10 clips were used to close the 5-6mm perforation site 10 clips were used to close the perforation.Pt was stable.The antibiotics and ct had been ordered and patient was to be admitted for observation.

• Brand Name: ENDOROTOR
• Common Device Name: ENDOSCOPIC MORCELLATOR
• Manufacturer (Section D): 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: 13804529
• Report Number: 3011697028-2022-00001
• Device Sequence Number: 10980519
• Product Code: PTE
• UDI-Device Identifier: 00854172008131
• UDI-Public: (01)00854172008131(17)230708(10)210708A
• 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
• 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: 07/08/2023
• Device Model Number: 3.2-EPR-COL-OP
• Device Catalogue Number: 3.2-EPR-COL-OP
• Device Lot Number: 21078A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2022
• Initial Report FDA Received Date: 03/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2021
• 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: Other
• Patient Sex: Unknown