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

Catalog Number 0250040112

Device Problems Break (1069); Structural Problem (2506)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/19/2019

Event Type  malfunction  

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 Description

It was reported that there was a possible breach in insulation due to alleged broken insulation which could result in adverse consequences due to arcing.

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.

Event Description

It was reported that there was a possible breach in insulation due to alleged broken insulation which could result in adverse consequences due to arcing.

• Brand Name: PKG. MONOPOLAR ELECTROSURGICAL PROBE, L-TIP, 33CM
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 9385519
• MDR Text Key: 175271328
• Report Number: 0002936485-2019-00526
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 37613327061346
• UDI-Public: 37613327061346
• Combination Product (y/n): N
• PMA/PMN Number: K934094
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0250040112
• Device Lot Number: 166666
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2019
• Date Manufacturer Received: 11/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1