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

Model Number	ER 10-01-OP
Health Effect - Clinical Code	Perforation (2001)
Date of Event	10/07/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
The physician was performing a resection in the colon of a previously resected polyp with scar tissue.An interscope representative was not present during this case.At the conclusion of the procedure the physician identified what appeared to be a partial perforation of the colon.A follow on ct scan confirmed the observation that the defect was not a complete perforation with peritoneal exposure.Patient was treated with three (3) endoscopic clips to close the defect.Patient was placed on antibiotics and kept in hospital for observation and discharged the following day.There was no evidence of a device malfunction and the device was not returned for investigation.

• Brand Name: ENDOROTOR
• Common Device Name: ENDOSCOPIC MORCELLATOR
• Manufacturer (Section D): INTERSCOPE, INC.; 100 main st suite 108; whitinsville MA 01588
• MDR Report Key: 9337038
• Report Number: 3011697028-2019-00001
• Device Sequence Number: 13992537
• Product Code: PTE
• UDI-Device Identifier: 00854172008001
• UDI-Public: (01)00854172008001(17)201204(10)525108C
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K181127
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/05/2019

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: 12/04/2020
• Device Model Number: ER 10-01-OP
• Device Catalogue Number: ER 10-01-OP
• Device Lot Number: 525108C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2019
• Initial Report FDA Received Date: 11/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention