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

Model Number ETHER420

Device Problems Activation, Positioning or Separation Problem (2906); Mechanics Altered (2984)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/07/2014

Event Type  malfunction  

Event Description

It was reported that during a laparoscopic cholecystectomy the device would not function correctly.Clips were not being loaded into the breach correctly.Clips were being loaded outside of the jaws.A second device also did not work properly.A third device was used to complete the procedure.The procedure was delayed to get another device.There was no patient injury.This report is being filed for the findings upon investigation.

Manufacturer Narrative

Final device evaluation found that the device was returned with a malformed clip jammed outside of the jaws, in a space between the plastic case/sheath on the distal end of the shaft and the jaws.Upon evaluation, the clip was removed and the device jaws resumed their normal aligned shape, with the push fork clearance being acceptable, and jaws being in alignment.The seven remaining clips were then fired.The clips were ejected at high speed out the device underneath the jaws.The jaws remained pinched together and were held in that position with a push fork pinning the jaws in a closed position with the insides of the push fork resting on the outside of the ridges on the grooved underside of the jaws.The jaws required manual manipulation to open, and again become properly aligned and not bent.This same pattern was followed upon each actuation of the trigger mechanism.It appeared that the push fork would slide underneath the jaws of the device, and the jaws would not open in time to receive the clip.After the last clip was fired, the locking mechanism did not engage as intended.It is possible that the space between the jaws and the plastic case/sheath was damaged and opened due to the jammed clip's path and position.The device history record was reviewed, and no discrepancies were noted.As each device is visually inspected and functionally tested prior to release, no conclusion could be made as to what may have caused the reported event.

• 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: 4068355
• MDR Text Key: 4736656
• Report Number: 2134070-2014-00155
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2015
• Device Model Number: ETHER420
• Device Catalogue Number: ER420
• Device Lot Number: 1745553
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2014
• 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 Age: 31 YR
• Patient Weight: 64