MAUDE Adverse Event Report: STERILMED, INC.

Model Number ETHER320

Device Problem Material Twisted/Bent (2981)

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

Event Date 05/17/2014

Event Type  malfunction  

Event Description

It was reported that during a laparoscopic cholecystectomy two devices were "twisting staples." no clips were successfully fired prior to the events.There was no torquing/twisting or resistance felt when firing the device.There were no unexpected noises or feeding issues.Cholangiogram was not done.The twisting issue occurred on the first firing of both devices.Another device was used to complete the procedure.There was no pt injury.This report is being filed for the second device.See mfr report #:2134070-2014-00115 regarding the first device.

Manufacturer Narrative

Final device investigation found that the device was returned in good visual condition with a clip in the jaw.The jaw appeared to be in alignment, and the clip retainer, push fork and jaw clearance were acceptable.Upon eval, the 13 remaining clips were fired.The first 4 clips loaded properly and had proper pinch and alignment.After th 4th clip, the device failed to load consistently, taking 2-3 actuations of the handle before a clip would load and fire.When fired, the clips had proper pinch and alignment.After the last clip was fired, the device locking mechanism did not engage.Further examination determined that there was a broken spring which caused the loading problem and failure to lock.It was not known whether the spring broke during device eval.The device history record was reviewed, and no discrepancies were noted.

• Brand Name: NA
• Manufacturer (Section D): STERILMED, INC.; maple grove MN
• Manufacturer Contact: tricia schrater ; 11400 73rd ave. north; maple grove, MN 55369 ; 7634883211
• MDR Report Key: 3950782
• MDR Text Key: 4642967
• Report Number: 2134070-2014-00121
• 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: Nurse
• Type of Report: Initial
• Report Date: 05/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2014
• Device Model Number: ETHER320
• Device Catalogue Number: ER320
• Device Lot Number: 1734582
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/19/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2013
• 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