MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE 24/26FR CONTINUOUS FLOW INNER/OUTER SHEATH; HYSTEROSCOPE (AND ACCESSORIES)

Catalog Number 0502880426

Device Problem Sticking (1597)

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

Event Date 08/15/2014

Event Type  malfunction  

Event Description

It was reported that the unit caught onto tissue.

Manufacturer Narrative

Upon additional information, bleeding occurred, thus constituting a new awareness.Additional information will be provided once the investigation has been completed.

Manufacturer Narrative

The product was returned and the failure mode was not confirmed.Visual inspection: no physical damage was seen on the sheath.In addition, no protrusions or sharp edges were seen on the distal tip.However, rust was seen on the stop cock.The probable root cause for the device catching on tissue is likely due to use error.The probable root causes for the rust on the stop cock could be due to 1) improper sterilization methods, 2) insufficient drying, or 3) improper storage conditions.In sum, the product was returned and the failure mode was not confirmed.

Event Description

It was reported that the unit caught onto tissue.

• Brand Name: 24/26FR CONTINUOUS FLOW INNER/OUTER 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: 4086325
• MDR Text Key: 4744895
• Report Number: 0002936485-2014-00709
• 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: 08/15/2014

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: 0502880426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/05/2014
• Initial Date FDA Received: 09/12/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/05/2014
• 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