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 Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that there was breach of insulation.
Additional Manufacturer Narrative
The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Alleged failure: it was reported by the sales rep (b)(6) they have had issues with 4-5 sheaths burning at the tip.The failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be 1) conductive irrigating or aspirating fluid used was inside the distal end, and contacted the probe and the sheath causing the sheath to melt, 2) power set too high.Manufacture date is not known.
Event or Problem Description
It was reported that there was breach of insulation.

• 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: 17726276
• Report Number: 0002936485-2023-00916
• Device Sequence Number: 5820411
• Product Code: GCJ
• UDI-Device Identifier: 07613327051872
• UDI-Public: 07613327051872
• Combination Product (Y/N): N
• 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): 06/20/2024

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: 22H5288
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/15/2023
• Initial Report FDA Received Date: 09/11/2023
• Supplement Report FDA Received Date: 06/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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