MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, MEDICAL POWER SUPPLY; CAMERA, TELEVISION, SURGICAL, WITHOUT AUDIO

Catalog Number 0240031004

Device Problem Device Inoperable (1663)

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

Event Date 06/30/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It has been reported by the technical services that the product is not working.There was a delay of 30-60 minutes.

Manufacturer Narrative

The product was returned and the failure mode was confirmed.Visual inspection: no visual damage outside the pkg, medical power supply.Functional inspection : power supply not working was verified using a vision pro monitor.Probable root cause/s could be a bad power supply.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 has been reported by the technical services that the product is not working.Additional information: there was a delay of 30-60 minutes.

• Brand Name: PKG, MEDICAL POWER SUPPLY
• Type of Device: CAMERA, TELEVISION, SURGICAL, WITHOUT AUDIO
• 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: 4947943
• MDR Text Key: 23092806
• Report Number: 0002936485-2015-00683
• Device Sequence Number: 1
• Product Code: FWB
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Report Date: 07/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 0240031004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/03/2015
• 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