MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE SHEATH, 2.9MM OPERATIVE INNER; HYSTEROSCOPE (AND ACCESSORIES)

Catalog Number 0502729061

Device Problem Thermal Decomposition of Device (1071)

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

Event Date 03/11/2014

Event Type  malfunction  

Event Description

It was reported that the end of the unit is burnt.

Manufacturer Narrative

The product was returned and the failure mode was confirmed.Visual inspection showed dents on shaft and burrs on distal tip.Burnt mark was noticed on the distal tip.Functional inspection was not performed due to damaged distal tip.Probable root causes could be user misuse or improper cleaning or sterilization.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 end of the unit is burnt.

Manufacturer Narrative

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

• Brand Name: SHEATH, 2.9MM OPERATIVE INNER
• 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: 3730158
• MDR Text Key: 4854572
• Report Number: 0002936485-2014-00189
• 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: 03/11/2014

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: Other
• Device Catalogue Number: 0502729061
• Device Lot Number: 1245874
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/11/2014
• Initial Date FDA Received: 04/07/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/10/2014
• 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