MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; SCALPEL, ULTRASONIC, REPROCESSED

Model Number ACE36E

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 05/01/2014

Event Type  Injury  

Event Description

It was reported that during the procedure, "the ace36e was involved with a patient injury." multiple attempts were made to gather additional information regarding this specific event.However, no other information was provided from the facility.

Manufacturer Narrative

The complaint device was not returned to stryker sustainability solutions (sss) for evaluation.Therefore, visual and functional inspection could not be performed.Despite multiple follow up attempts with the facility, no additional information was provided regarding this event.As the lot number was not reported, the device history record could not be reviewed.The reported event is not occurring more frequently or with greater severity than is usual for the device.Device not returned.

• Brand Name: NA
• Type of Device: SCALPEL, ULTRASONIC, REPROCESSED
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; 5307 great oak drive; lakeland FL 33815
• Manufacturer (Section G): STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; 5307 great oak drive; lakeland FL 33815
• Manufacturer Contact: moira barton varty ; 1810 w. drake drive; tempe, AZ 85283 ; 8888883433
• MDR Report Key: 3846409
• MDR Text Key: 4614798
• Report Number: 0001056128-2014-00065
• Device Sequence Number: 1
• Product Code: NLQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043315
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ACE36E
• Device Catalogue Number: ACE36ERR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other