MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG. MONOPOLAR ELECTROSURGICAL PROBE, L-TIP, 33CM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	0250040112
Medical Device Problem Code	Device Difficult to Maintain (3134)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/19/2019
Type of Reportable Event	Malfunction
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 there was a potential breach in insulation which could further result in adverse consequences due to arcing.
Event or Problem Description
It was reported that there was a potential breach in insulation which could further result in adverse consequences due to arcing.
Additional Manufacturer Narrative
Alleged failure: update: during medical procedure, the ending of l-tip electrosurgical has rift.This product was delivered to hospital in y2015.It was not using until (b)(6) 2019.The customer want to know storage conditaion, ser guidance,sterilization method of this product.¿ besides, they want to know why l-tip electrosurgical only can be used 20 times? "during medical procedure, the surgeon used l-tip electrosurgical probepk3 caused burn.The handle of l-tip electrosurgical has rift.When the liquid dropped in rift of handle which lead to conduction and caused burn.This product was delivered to hospital in y2015.It was not using until (b)(6) 2019.The customer want to know storage conditaion, ser guidance,sterilization method of this product.¿ the failure(s) 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.

• Brand Name: PKG. MONOPOLAR ELECTROSURGICAL PROBE, L-TIP, 33CM
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 9385647
• Report Number: 0002936485-2019-00527
• Device Sequence Number: 16769218
• Product Code: GCJ
• UDI-Device Identifier: 37613327061346
• UDI-Public: 37613327061346
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K934094
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2020

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: 0250040112
• Device Lot Number: 163584
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2019
• Initial Date Received by Manufacturer: 11/06/2019
• Supplement Date Received by Manufacturer: 11/06/2019
• Initial Report FDA Received Date: 11/27/2019
• Supplement Report FDA Received Date: 02/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1