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

Model Number	0250070443
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2021
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 the heat shrink and sheath melted.
Additional Manufacturer Narrative
Alleged failure: yellow heat shrink and sheath are melting, causing compromised insulation.No adverse consequences to patient.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.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 heat shrink and sheath melted.

• 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
• MDR Report Key: 11958581
• Report Number: 0002936485-2021-00295
• Device Sequence Number: 3925894
• Product Code: GCJ
• UDI-Device Identifier: 07613327051872
• UDI-Public: 07613327051872
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 07/14/2021

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 Model Number: 0250070443
• Device Catalogue Number: 0250070443
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2021
• Initial Date Received by Manufacturer: 05/10/2021
• Supplement Date Received by Manufacturer: 05/10/2021
• Initial Report FDA Received Date: 06/08/2021
• Supplement Report FDA Received Date: 07/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1