MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE 24FR STANDARD FLOW RESECTOSCOPE SHEATH; HYSTEROSCOPE (AND ACCESSORIES)

Catalog Number 0502880324

Device Problems Break (1069); Detachment Of Device Component (1104)

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

Event Date 03/31/2015

Event Type  malfunction  

Event Description

It was reported that the distal tip broke off during a case.

Manufacturer Narrative

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

Manufacturer Narrative

The product was returned and the failure mode was confirmed.Visual inspection: a piece of the ceramic tip broke off.Refer to the attached picture.The piece that broke off was not received with the device.The probable root causes for the reported failure involving this device could be due to 1) user excessive force or 2) dropping/banging of the device against a hard surface.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 distal tip broke off during a case.

• Brand Name: 24FR STANDARD FLOW RESECTOSCOPE SHEATH
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• 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: thomas shafer ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 4728840
• MDR Text Key: 5583531
• Report Number: 0002936485-2015-00315
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040390
• 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: 03/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0502880324
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/31/2015
• Initial Date FDA Received: 04/24/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/02/2015
• 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