MAUDE Adverse Event Report: STERILMED, INC. STERILMED LIGASURE 5MM MARYLAND JAW SEALER/DIVIDER; ENDOSCOPIC ELECTROSURGICAL HANDPIECE/ELECTRODE, BIPOLAR, REPROCESSED

Catalog Number	COVLF1737
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Shock (2072); Blood Loss (2597)
Date of Event	01/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.Since no lot number was provided, no device history record (dhr) review could be performed.(b)(4).
Event or Problem Description
It was reported that a patient underwent a gastrectomy procedure with a sterilmed ligasure 5mm maryland jaw sealer/divider and suffered bleeding.The physician had to reopen a bariatric patient after a sleeve gastrectomy because of post-operative bleeding.The surgeon said bleeding was coming from two vessels sealed with a sterilmed ligasure maryland.The same day urgent reoperation was done to stop the bleeding.Patient was doing well after reoperation.
Additional Manufacturer Narrative
Additional information was received on october 15, 2018.The short gastric vessels approximately 5 mm in size were taken with the ligasure.There were no issues with the device.The patient required a transfusion of 4 units of blood and was in hemorrhagic shock 6 hours after surgery.Manufacturer's ref.No: (b)(4).

• Brand Name: STERILMED LIGASURE 5MM MARYLAND JAW SEALER/DIVIDER
• Common Device Name: ENDOSCOPIC ELECTROSURGICAL HANDPIECE/ELECTRODE, BIPOLAR, REPROCESSED
• Manufacturer (Section D): STERILMED, INC.; 5010 cheshire parkway; ste 2; plymouth MN 55446
• MDR Report Key: 7943079
• Report Number: 2134070-2018-00108
• Device Sequence Number: 19417654
• Product Code: NUJ
• UDI-Device Identifier: 10888551044462
• UDI-Public: 10888551044462
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K143260
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2018

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?: Yes
• Operator of Device: No Information
• Device Catalogue Number: COVLF1737
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/25/2018
• Supplement Date Received by Manufacturer: 10/15/2018
• Initial Report FDA Received Date: 10/08/2018
• Supplement Report FDA Received Date: 11/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention