MAUDE Adverse Event Report: ENDOCHOICE, INC. AUTOBAND; MULTIPLE BAND LIGATOR

Model Number	DBL-330
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was discarded, making further investigation impossible.
Event or Problem Description
During variceal ligation, the elastic bands did not deploy.The edge of the barrel caused bleeding at the base of the varix which had not been bleeding previously.The banding device was checked before starting endoscopy and functioned, but did not work during the case.

• Brand Name: AUTOBAND
• Common Device Name: MULTIPLE BAND LIGATOR
• Manufacturer (Section D): ENDOCHOICE, INC.; 11810 wills road; alpharetta GA 30009 2081
• MDR Report Key: 6816539
• Report Number: 3007591333-2017-00037
• Device Sequence Number: 121499
• Product Code: MND
• UDI-Device Identifier: 00816849010007
• UDI-Public: 00816849010007
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K132535
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 08/24/2017

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: Physician
• Device Expiration Date: 10/26/2017
• Device Model Number: DBL-330
• Device Catalogue Number: DBL-330
• Device Lot Number: 157043
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2017
• Initial Report FDA Received Date: 08/24/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 62 YR
• Patient Weight: 60