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

Catalog Number 0502729061

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem No Patient Involvement (2645)

Event Date 10/15/2015

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 that the distal end fell off.There were no report of patient involvement and adverse consequences.

Manufacturer Narrative

Tip damaged was observed.Functional inspection : probable root cause could be improper sterilization methods, contact force with hard surface/ other surgical instrument.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 end fell off.There were no report of patient involvement and adverse consequences.

• 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: kimberly lynch ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 5212865
• MDR Text Key: 31059552
• Report Number: 0002936485-2015-01020
• 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: 10/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 0502729061
• Device Lot Number: ¿1311253¿
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/15/2015
• 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