MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT CLEAR LIGATOR 5 BAND; STEIGMANN-GOFF ENDOSCOPIC LIGATOR

Model Number	000221
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint is inconclusive.The device will not be returned for evaluation and no photographic evidence has been provided.Therefore, the reported issue cannot be verified.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution were found to have met all specifications prior to shipment.This is the only complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been 1 complaint regarding 2 devices for this device family and failure mode.During the same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed, the rate of failure would be (b)(4).Per the instructions for use, the user is advised the following; ligation bands may be difficult to apply to small varices.It is recommended that reuse of the overtube be limited to no more than twenty-five (25) uses, even when recommended cleaning and disinfection instructions are followed.Performance characteristics may deteriorate beyond the recommended number of uses.A determination for further investigation has been initiated.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The conmed representative reported on behalf of the facility that the 000221, clear ligator 5 band kit, broke during an egd on (b)(6) 2019.He reported that the doctor was doing esophageal banding and the band broke off and he had to fish out with a net.The procedure was completed using another of the same product.There was no reported delay in procedure.There was no patient injury reported, although the band almost went into the patient's lung.This report is being raised as device malfunction with potential for injury upon reoccurrence.

• Brand Name: CLEAR LIGATOR 5 BAND
• Common Device Name: STEIGMANN-GOFF ENDOSCOPIC LIGATOR
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT; alejandro dumas ave, 11321; complejo industrial chihuahua; 31136 ; MX 31136
• MDR Report Key: 8636061
• Report Number: 3007305485-2019-00183
• Device Sequence Number: 2386785
• Product Code: MND
• UDI-Device Identifier: 10653405053651
• UDI-Public: (01)10653405053651(17)210307(10)201903084
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K940661
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/07/2021
• Device Model Number: 000221
• Device Catalogue Number: 000221
• Device Lot Number: 201903084
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2019
• Initial Report FDA Received Date: 05/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1