MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG. MONOPOLAR ELECTROSURGICAL PROBE, L-TIP, 45CM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	0250040117
Medical Device Problem Code	Electrical Shorting (2926)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.
Event or Problem Description
It was reported that the product delivered unintended energy to the surgical site and caused patient harm.
Additional Manufacturer Narrative
The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.Alleged failure: (b)(6) called in complaint for 2x 0250040117.Probe had arcing and caused harm.Another source of energy that caused cauterizing to jump to different area.This occurred during 2 cases within a week time span.The failure identified in the investigation is consistent with the complaint record.The probable root causes could be third party repair.The device manufacture date is not known.
Event or Problem Description
It was reported that the product delivered unintended energy to the surgical site and caused patient harm.

• Brand Name: PKG. MONOPOLAR ELECTROSURGICAL PROBE, L-TIP, 45CM
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 8862132
• Report Number: 0002936485-2019-00331
• Device Sequence Number: 11360393
• Product Code: GCJ
• UDI-Device Identifier: 37613327061384
• UDI-Public: 37613327061384
• 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): 02/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0250040117
• Device Lot Number: 246689
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2019
• Initial Date Received by Manufacturer: 07/12/2019
• Supplement Date Received by Manufacturer: 07/12/2019
• Initial Report FDA Received Date: 08/05/2019
• Supplement Report FDA Received Date: 02/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other