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	Arcing (2583)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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
Alleged failure: hunter called in complaint for (b)(4).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.1 patient harmed, no additional information.Still conducting investigation.Adverse consequences? explain.Just that one patient was injured, no detail was given to the extent.No further data was given to me.The failure identified in the investigation is consistent with the complaint record.The probable root cause could be third party repair.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 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: 8862084
• Report Number: 0002936485-2019-00330
• Device Sequence Number: 16741773
• 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): 12/06/2019

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: 12/06/2019
• 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