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

Catalog Number 0250040112

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn, Thermal (2530)

Event Date 04/30/2019

Event Type  Injury  

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 the patient was burned.

Manufacturer Narrative

Alleged failure: it has been reported by the customer that during a laparoscopic cholecystectomy the patient was burned due to microperforations in the protective.Sheath of the 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.The device manufacturer date is not known.

Event Description

It was reported that the patient was burned.

• 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: 8655066
• MDR Text Key: 146617545
• Report Number: 0002936485-2019-00224
• 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: consumer
• Type of Report: Initial,Followup
• Report Date: 08/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0250040112
• Device Lot Number: 300816
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2019
• Date Manufacturer Received: 05/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1