MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS, INC. N/A; SCALPEL, ULTRASONIC, REPROCESSED

Model Number N/A

Device Problem Connection Problem (2900)

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

Event Date 12/02/2016

Event Type  malfunction  

Event Description

During case re-processed harmonic scalpel handpiece would not connect to the cord.Dr did not want a replacement.Manufacturer response for harmonic scalpel, (brand not provided) (per site reporter): they will initiate a quality control investigation and provide us with replacement product.

• Brand Name: N/A
• Type of Device: SCALPEL, ULTRASONIC, REPROCESSED
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS, INC.; 1810 w. drake dr.; tempe AZ 85283
• MDR Report Key: 6303411
• MDR Text Key: 66575350
• Report Number: 6303411
• Device Sequence Number: 1
• Product Code: NLQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/04/2017,01/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Unknown
• Device Expiration Date: 08/03/2017
• Device Model Number: N/A
• Device Catalogue Number: HAR36
• Device Lot Number: 4785366
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/04/2017
• Event Location: Hospital
• Date Report to Manufacturer: 01/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 32 YR