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

Catalog Number	7209686
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/13/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a shoulder arthroscopic surgery, the metal piece disappeared, no x-rays were performed to confirmed if the metal piece melt or fell off inside the patient's anatomy.No patient injuries reported.Back-up device was available to complete the surgery.
Additional Manufacturer Narrative
An evaluation was performed by smith and nephew and could not confirm the customer complaint for the metal piece disappeared.A visual inspection was performed and showed the distal tip is broken off the probe and there is insulation damage.The loose tip was viewed under microscopic inspection and showed the metal on the tip and the metal on the probe are curved where the tip snapped off indicating excessive force was applied.A dhr review was performed and showed no non conformance's or deviations associated with the lot number provided.No manufacturing related defects were observed.

• 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: 8957004
• Report Number: 3003604053-2019-00112
• Device Sequence Number: 2609302
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2019

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 Catalogue Number: 7209686
• Device Lot Number: 2019591
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2019
• Initial Date Received by Manufacturer: 08/13/2019
• Supplement Date Received by Manufacturer: 10/08/2019
• Initial Report FDA Received Date: 09/03/2019
• Supplement Report FDA Received Date: 10/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 30 YR
• Patient Weight: 47