MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE 5MM PEEK MULTIFUNCTION HANDLE; ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED

Catalog Number 0250181106

Device Problems Break (1069); Crack (1135); Device Operates Differently Than Expected (2913)

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

Event Date 01/12/2016

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.

Event Description

It was reported that the shaft insulation cracked, compromised, broke, or breached.Insulscan failed.

Manufacturer Narrative

(b)(4).The product was returned and the failure mode was confirmed.Visual inspection: cracked insulation observed.Ifu states: "before use, ensure that there are no breaks, chips, cracks, scratches, tears, or missing/loose components on the shaft insulation, handle, or housing.Do not use the instrument if any of these defects are present as this could cause unintended electrosurgical burns and life threatening complications.If damage has occurred, discontinue use and return the instrument for repair or replacement." functional inspection: the insulation was tested with an insulscan device.The insulation failed the insulscan test.The probable root causes for the reported failure involving this device could be due to improper sterilization methods, rapid cooling after sterilization, contact with metal tray during sterilization, or normal wear and tear.The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.

Event Description

It was reported that the shaft insulation cracked, compromised, broke, or breached.Insulscan failed.

• Brand Name: 5MM PEEK MULTIFUNCTION HANDLE
• Type of Device: ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: kimberly lynch ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 5408581
• MDR Text Key: 37785624
• Report Number: 0002936485-2016-00120
• Device Sequence Number: 1
• Product Code: OCZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K973259
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 0250181106
• Device Lot Number: ¿1446424H¿
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1