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

Model Number	ASC4250-01
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to stryker sustainability solutions for evaluation.Visual inspection of the returned complaint device revealed evidence of clinical use.The electrodes were damaged and the suction plate was detached.The suction plate was returned in a sample container with the complaint device.A review of the dhr supports that the device met all inspection and test criteria prior to release from stryker.Therefore, the most likely root cause is too much force applied to device during use.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.The reported event will continue to be monitored through post-market surveillance.
Event or Problem Description
It was reported the tip of the arthroscopic wand fell off in the patient.The tip was retrieved successfully during the same procedure with minimal delay and no additional intervention was needed.There was no patient injury reported.These are commonly used devices that are readily available.

• Brand Name: NA
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC,
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; 5307 great oak drive; lakeland FL 33815
• MDR Report Key: 6785018
• Report Number: 0001056128-2017-00105
• Device Sequence Number: 18983478
• Product Code: NUJ
• UDI-Device Identifier: 00885825014315
• UDI-Public: (01)00885825014315(17)200131(10)5759827
• 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): 08/10/2017

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 Expiration Date: 01/31/2020
• Device Model Number: ASC4250-01
• Device Catalogue Number: ASC4250-01RR
• Device Lot Number: 5759827
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2017
• Initial Report FDA Received Date: 08/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1