MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG,STRYKEFLOW ELECROCAUTERY PROBE, SPATULA TIP, 5MM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	0250070441
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/25/2019
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 a breach in the insulation.
Additional Manufacturer Narrative
This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: arcing probable root cause: generator power malfunction; material/design error; conductive irrigant used; manufacturing / assembly error; user error.The device manufacturer date is not known.
Event or Problem Description
It was reported that there was a breach in the insulation.

• Brand Name: PKG,STRYKEFLOW ELECROCAUTERY PROBE, SPATULA 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: 8906278
• Report Number: 0002936485-2019-00349
• Device Sequence Number: 14090260
• Product Code: GCJ
• UDI-Device Identifier: 07613327051865
• UDI-Public: 07613327051865
• 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): 09/18/2019

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: No Information
• Device Catalogue Number: 0250070441
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/26/2019
• Supplement Date Received by Manufacturer: 07/26/2019
• Initial Report FDA Received Date: 08/19/2019
• Supplement Report FDA Received Date: 09/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1