MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG., ASSY., SUCTION / IRRIGATOR 2; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number 0250070500

Device Problem Fluid/Blood Leak (1250)

Patient Problem Skin Irritation (2076)

Event Date 02/07/2019

Event Type  malfunction  

Manufacturer Narrative

The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.

Event Description

It was reported of potential superficial skin irritation from fluid leaking out of the battery.Please note that staff members were not wearing gloves and got this fluid on their hands and sought medical attention after being exposed to the fluid.

Event Description

It was reported of potential superficial skin irritation from fluid leaking out of the battery.Please note that staff members were not wearing gloves and got this fluid on their hands and sought medical attention after being exposed to the fluid.

Manufacturer Narrative

Alleged failure: it was reported that the product was leaking onto the battery chamber.Allegedly, the battery exploded injuring three hospital employees and the fluid went all over the operating room.It was reported that smoke from the explosion caused employees to get headaches.The failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be fluid ingress.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.

• Brand Name: PKG., ASSY., SUCTION / IRRIGATOR 2
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 8390806
• MDR Text Key: 138237100
• Report Number: 0002936485-2019-00087
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 37613327061391
• UDI-Public: 37613327061391
• Combination Product (y/n): N
• PMA/PMN Number: K934094
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0250070500
• Device Lot Number: 18351FG2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2019
• Date Manufacturer Received: 02/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1