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

Model Number	7209686
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during a shoulder arthroscopy, the probe head has no positive energy output and cannot be used while being used in default settings.The probe head is for single use.The host shutdown and restart still can not be used, finally a new probe head was used to complete the surgery with a delay greater than 30 minutes.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The reported device, used in treatment, was received for evaluation.There was no relationship found between the returned device and the reported incident.A visual inspection found no issues.A functional evaluation found the probe functioned as intended.The probe was tested at various settings and all tests found the probe to pass energy through the electrode appropriately.A review of the customer provided image confirmed the product and lot number of the device returned for investigation.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review concluded this was an isolated event.The complaint was not verified and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.

• Brand Name: PROBE SAPHYRE 90DEG
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 11158139
• Report Number: 3003604053-2021-00008
• Device Sequence Number: 3920678
• Product Code: GEI
• UDI-Device Identifier: 03596010470560
• UDI-Public: 03596010470560
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K991218
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2021

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: 11/27/2022
• Device Model Number: 7209686
• Device Catalogue Number: 7209686
• Device Lot Number: 2045646
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2021
• Initial Date Received by Manufacturer: 12/21/2020
• Supplement Date Received by Manufacturer: 10/14/2021
• Initial Report FDA Received Date: 01/12/2021
• Supplement Report FDA Received Date: 10/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 72