MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PROBE SAPHYRE 90DEG; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number 7209686

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/07/2023

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference case- (b)(4).

Event Description

It was reported that on (b)(6) 2023, a left shoulder arthroscopic exploration and cleaning, adhesion release, subacromial bursa resection and acromioplasty were performed in the operating room under general anesthesia.After the surgery was completed, and the incision had been closed.When the nurse counted the surgical items, it was noticed, that the electrode blade at the front end from the saphyre probe was missing.An x-ray was performed and reviewed on the same day.Which suggested, there was a metal foreign body under the patient's left acromion, with a diameter of about 1.8 mm.On the morning of (b)(6), the patient was satisfied with a relief of his symptoms.No discomfort was reported.Since the reported remaining fragments were very small, the doctors did not consider them to be of much consequence.It was then decided, with the patient's consent, that an additional operation would not be scheduled to remove the remaining fragments.

Manufacturer Narrative

H10: h3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found similar reported events.The instructions for use were reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A clinical review states that the provided x-ray image confirms the retained fragment.Based on the information provided, the clinical root cause of the retained electrode fragment cannot be determined.The device ifu warns to avoid probe contact with the arthroscope, as this could damage the probe and/or scope and could leave debris in the joint.Additionally, mechanically manipulating tissue could damage the active electrode tip and could leave debris in the joint.Therefore, user error cannot be ruled out as a contributing factor to the reported event.The saphyre probe is an external communicating device, and its electrode tip is neither manufactured nor intended for implantation and should have limited tissue/bone contact as long-term implantation data is not available.Although the patient did not report any discomfort the following day, the potential for micromotion and/or migration cannot be ruled out.The root cause of the reported event could not be determined.Factors that could have contributed to the reported event include impact or inappropriate force exerted on the distal tip.No containment or corrective actions are recommended at this time.

• Brand Name: PROBE SAPHYRE 90DEG
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 17821624
• MDR Text Key: 324321383
• Report Number: 3003604053-2023-00042
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 03596010470560
• UDI-Public: 03596010470560
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K991218
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2024
• Device Catalogue Number: 7209686
• Device Lot Number: 2075247
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/11/2023
• Initial Date FDA Received: 09/26/2023
• Supplement Dates Manufacturer Received: 10/26/2023
• Supplement Dates FDA Received: 10/29/2023
• Date Device Manufactured: 06/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 51 YR
• Patient Sex: Female