MAUDE Adverse Event Report: STANDARD BARIATRICS STANDARD CLAMP, DISPOSABLE; SURGICAL CLAMP

Model Number	SCD25
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	12/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Standard bariatrics originally submitted 3012481535-2018-00001 within the required 30 day timeframe.The mdr was inadvertently sent to the pre-production account due to a link provided by the esg helpdesk for an issue with our production account.The file is being submitted (b)(6) 2018 to the esg production account to correct this error.
Event or Problem Description
The standard clamp, disposable was being used in a sleeve gastrectomy procedure to grasp and clamp the stomach.The physician opened the clamp jaws and was unable to fully close them by activating the trigger on the handpiece (jaws closed partially).The user manually closed the jaws and removed the device from the trocar.The device was replaced with a new standard clamp, disposable and the procedure was completed without any patient consequence.No adverse event occurred.

• Brand Name: STANDARD CLAMP, DISPOSABLE
• Common Device Name: SURGICAL CLAMP
• Manufacturer (Section D): STANDARD BARIATRICS; 4362 glendale milford rd.; cincinnati,
• MDR Report Key: 7306261
• Report Number: 3012481535-2018-00001
• Device Sequence Number: 1067124
• Product Code: GCJ
• UDI-Device Identifier: 00851677007003
• UDI-Public: 00851677007003
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K170379
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/20/2018

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: Physician
• Device Model Number: SCD25
• Device Catalogue Number: SCD25-1
• Device Lot Number: 110817-0001-2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2017
• Initial Report FDA Received Date: 03/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 40 YR