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

Catalog Number 0502729061

Device Problem Break (1069)

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

Event Date 10/23/2014

Event Type  malfunction  

Event Description

It was reported that the tip is sheared.

Manufacturer Narrative

Upon receipt of the device a new failure mode was discovered.The reportability date has been updated in block g4 with a new awareness date.The product was returned and the failure mode was confirmed.Visual inspection found pieces of the tip are broken off.The broken off pieces were not received with the device.The probable root cause for the sheared tip is likely due to 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.

• 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: 4306545
• MDR Text Key: 5133028
• Report Number: 0002936485-2014-00998
• 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
• Report Date: 10/23/2014

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: 1281506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2014
• Initial Date Manufacturer Received: 11/13/2014
• Initial Date FDA Received: 12/08/2014
• 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