MAUDE Adverse Event Report: STERILMED, INC.; CLIP APPLIER

Model Number ETHER320

Device Problems Failure to Cycle (1142); Difficult or Delayed Positioning (1157); Failure to Form Staple (2579)

Patient Problem Blood Loss (2597)

Event Type  Injury  

Event Description

It was reported that the device was defective and there was patient injury.It was later reported that during a laparoscopic cholecystectomy the clip came out but was not actually clipping.The clip was halfway closed, in a tear drop shape "like an aneurysm clip." then the next clip would not come fully out into the jaws, and the trigger had to be actuated several times.Resistance was felt from the trigger when the device was actuated.This occurred while trying to clip the cystic artery."multiple devices" were opened before changing to a similar device of another manufacturer.The case was converted to open because the bleeding could not be stopped, and hemostasis could not be achieved.It was not believed that any blood products were used.The patient was fine and discharged after the procedure.No cholangiogram had been performed.The device was reported as being held by the user facility.Additional information was requested.A supplemental report will be sent if additional information is received.

Manufacturer Narrative

The device was not returned to the manufacturer as of the date of this report and was reportedly being held by the user facility.

• Brand Name: NA
• Type of Device: CLIP APPLIER
• Manufacturer (Section D): STERILMED, INC.; maple grove MN
• Manufacturer Contact: tricia schrater ; 11400 73rd ave. north; maple grove, MN 55369 ; 7634883211
• MDR Report Key: 4105928
• MDR Text Key: 15813424
• Report Number: 2134070-2014-00170
• Device Sequence Number: 1
• Product Code: NMJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033579
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ETHER320
• Device Catalogue Number: ER320
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention