MAUDE Adverse Event Report: STERILMED, INC.; LAPAROSCOPIC SCISSORS

Model Number ETH5DCS

Device Problems Bent (1059); Material Integrity Problem (2978)

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

Event Date 08/06/2014

Event Type  malfunction  

Event Description

It was reported that the device shaft was bent and the insulation was compromised.Another device was used to complete the case.There was no patient injury.Additional information was requested, but no additional information was available.

Manufacturer Narrative

Final device investigation found that the device was returned with a pronounced bend in the shaft and damage to the insulation.Upon evaluation, the device passed mechanical testing - the jaw fully opened and closed and was able to pass the cut test.The device then was electrically tested and failed the insulation test.Under magnification, the insulation appeared rough and had marks were it may have been scraped or damaged.At one point, metal could be seen inside one of the scrape marks.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: LAPAROSCOPIC SCISSORS
• Manufacturer (Section D): STERILMED, INC.; maple grove MN
• Manufacturer Contact: tricia schrater ; 11400 73rd ave. north; maple grove, MN 55369 ; 7634883211
• MDR Report Key: 4068447
• MDR Text Key: 4811783
• Report Number: 2134070-2014-00157
• Device Sequence Number: 1
• Product Code: NUJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K012598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/06/2014

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: 05/01/2015
• Device Model Number: ETH5DCS
• Device Catalogue Number: 5DCS
• Device Lot Number: 1763762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/06/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2014
• 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