MAUDE Adverse Event Report: STERILMED, INC.

Model Number ETHER320

Device Problems Mechanical Problem (1384); 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.On the second firing of the first device, three clips came out at once.Another device was used to complete the procedure.There was no pt injury.This report is being filed for the first device.See mfr report #: 2134070-2014-00116 regarding the second device.

Manufacturer Narrative

Final device investigation found that the device was returned with a clip in the jaw not properly aligned, possibly due to transport or use.The jaw appeared to be in alignment and the clip retainer, push fork and jaw clearance were acceptable.Upon eval, the clip returned in the jaw, and the other eight remaining clips were fired.The clip that was misaligned in the jaw was twisted after firing.The remaining eight clips were cycled, fed and formed as intended with proper pinch and alignment.After the last clip was fired, the locking mechanism engaged as designed.As the device performed as intended after the first misaligned clip was removed, no conclusion could be made as to what may have caused the reported event.

• 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: 3950761
• MDR Text Key: 4644063
• Report Number: 2134070-2014-00120
• 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 Model Number: ETHER320
• Device Catalogue Number: ER320
• 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: 01/01/2014
• 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