MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE 5MM, 45CM PEEK MULTI-FUNCTION HANDLE; ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED

Catalog Number 0250181108

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

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

Event Date 02/02/2016

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.

Event Description

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

Manufacturer Narrative

(b)(4).The device manufacture date is not known at this time.The product was returned and the failure mode was confirmed.The handle was visually inspected for damages, and the insulation is cracked near the distal tip.The instrument failed the insul scan test near the distal end of the insulation.The probable root cause/s could be normal wear, improper sterilization methods or user misuse.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 the insulation cracked, compromised, broke, or breached.Insulscan failed.

• Brand Name: 5MM, 45CM PEEK MULTI-FUNCTION 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: 5458708
• MDR Text Key: 39304185
• Report Number: 0002936485-2016-00195
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 0250181108
• Device Lot Number: ¿1243551D¿
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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