MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE UNKNOWN_ENDOSCOPY_PRODUCT

Catalog Number UNK_END

Device Problem Detachment Of Device Component (1104)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/01/2013

Event Type  Injury  

Manufacturer Narrative

The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.Additional information will be provided once the investigation has been completed.The reported device is listed as unknown, therefore the gtin cannot be confirmed at this time.

Event Description

It was reported that part of the blade remained inside of the patient.The procedure was completed successfully.

Manufacturer Narrative

The device manufacture date is not known.The product was not returned for investigation therefore the reported failure mode was not confirmed.Probable root cause for the reported failure involving this device could not be determined due to insufficient information.The reported failure mode will be monitored for future reoccurrence.Gtin: the reported device is listed as unknown, therefore the gtin cannot be confirmed.

Event Description

It was reported that part of the blade remained inside of the patient.The procedure was completed successfully.

• Brand Name: UNKNOWN_ENDOSCOPY_PRODUCT
• Type of Device: UNK
• 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: valerie estrada ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 7487921
• MDR Text Key: 107439740
• Report Number: 0002936485-2018-00393
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_END
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1