MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, R

Model Number	ASC4250-01
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to stryker sustainability solutions for evaluation.It was stated the device was discarded.As the device was not returned for evaluation inspection was unable to be performed.No device information was reported as the device was not returned to stryker sustainability solutions.Therefore, the device history record (dhr) was unable to be verified.The reported event could be attributed to: - not inspecting device prior to use, - too much force applied to device, - shipping/handling damage subsequent to distribution from stryker.The instructions for use (ifu) state: - always inspect instrument carefully for overall integrity before use.- do not allow the arthroscopic wand or electrode to come into contact with staples, clips or any metal object while it is energized.- become familiar with specific arthroscopic wand or electrode model prior to employing it in a surgical procedure to avoid damage to patient, operator or instrument.- careful handling of the instruments is necessary to avoid damage or breakage as a result of excessive force.- vigorous use against bony surfaces may result in excessive wear of the electrodes.- inspect the instrument for overall condition and physical integrity.Do not use the instrument if any damage is noted.Return the instrument and packaging to stryker sustainability solutions if it is not in acceptable condition for surgery.- before beginning the procedure, verify overall compatibility for all instruments and accessories.- select an arthroscopic wand or electrode with the size, tip angle and function most appropriate to the procedure.Should the device become available for return, the investigation will be reopened.The reported event will continue to be monitored through post-market surveillance.(b)(4).
Event or Problem Description
It was reported that during a routine follow up to a shoulder arthroscopy, a piece of metal was identified in the x-ray and was determined to be the tip of an arthrowand.The patient currently has no pain and there is no plan to remove the tip unless it causes an issue in the future.

• Brand Name: NA
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, R
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; 5307 great oak drive; lakeland FL 33815
• MDR Report Key: 6546602
• Report Number: 0001056128-2017-00067
• Device Sequence Number: 13609813
• Product Code: NUJ
• UDI-Device Identifier: 00885825014315
• UDI-Public: (01)00885825014315
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K043198
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ASC4250-01
• Device Catalogue Number: ASC4250-01RR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2017
• Initial Report FDA Received Date: 05/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1