MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, STRYKERFLOW ELECTROCAUTERY PROBE, L TIP, 5MM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	0250070443
Medical Device Problem Codes	Electrostatic Discharge (2149); Temperature Problem (3022)
Health Effect - Clinical Codes	Burn(s) (1757); Shock (2072)
Date of Event	06/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the user was burned and shocked.The burn was minor and did not require medical intervention.
Additional Manufacturer Narrative
The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.Additional information will be provided once the investigation has been completed.
Additional Manufacturer Narrative
Alleged failure: it was reported by the sales rep (b)(4) a surgeon was using the l-tip then felt a shock burn on his thumb and tossed the l-tip off the field update: do not know degree of burn, i saw the burn it is very tiny maybe 1cm long, 1mm wide.The surgeon finished the case after changing gloves, and did another case right after it with no issue.The failures identified in the investigation is consistent with the complaint record.The probable root causes could be conductive irrigating or aspirating fluid used was inside the distal end, and contacted the probe and the sheath causing the sheath to melt, power set too high.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Manufacture date is not known.
Event or Problem Description
It was reported that the user was burned and shocked.The burn was minor and did not require medical intervention.

• Brand Name: PKG, STRYKERFLOW ELECTROCAUTERY PROBE, L TIP, 5MM
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: chester rebugio ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 17385899
• Report Number: 0002936485-2023-00719
• Device Sequence Number: 12337897
• Product Code: GCJ
• UDI-Device Identifier: 07613327051872
• UDI-Public: 07613327051872
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K934094
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2024

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: 0250070443
• Device Lot Number: 040617-04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/27/2023
• Supplement Date Received by Manufacturer: 06/27/2023
• Initial Report FDA Received Date: 07/24/2023
• Supplement Report FDA Received Date: 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown