MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SMITH & NEPHEW 500 INSUFFLATOR; INSUFFLATOR, LAPAROSCOPIC

Catalog Number 72203994

Device Problem Insufficient Information (3190)

Patient Problems Hemorrhage/Bleeding (1888); High Blood Pressure/ Hypertension (1908)

Event Date 04/14/2018

Event Type  malfunction  

Event Description

It was reported that the dr.Had connected machine to the patient and started surgery by creating pneumoperitoneum with the insufflator.After some time they noticed that the patient's pressure had increased very high and also noticed bleeding from peritoneal layer.When they looked at the insufflator pressure, it was showing 12 mmhg actual pressure as same as set pressure but gas was flowing continuously.Immediately they stopped flow and with great effort they stopped bleeding.They finished surgery with standby machine.

Manufacturer Narrative

The device, a 72203994 - smith & nephew 500 insufflator serial number (b)(4) , was received for evaluation.There was no relationship found between the returned device and the reported incident.A visual inspection was performed and the product number and serial number were verified.No deficiencies were observed.No co2 input cap or accessory or ancillary products were returned with the device.A functional evaluation did not reveal any problems.The unit powered up and no error messages occurred.The complaint was not verified and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.A review of the device history records show there are no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.Please refer to the smith & nephew 500 insufflator operator's manual for troubleshooting suggestions and probable causes of problems encountered.The device has been sent to the original equipment manufacturer (oem) for further evaluation.

• Brand Name: SMITH & NEPHEW 500 INSUFFLATOR
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• Manufacturer Contact: jim gonzales ; 7000 west william cannon drive; austin, TX 78735
• MDR Report Key: 7488996
• MDR Text Key: 107438352
• Report Number: 1643264-2018-00339
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 03596010673497
• UDI-Public: (01)03596010673497
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K120151
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/24/2018

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 72203994
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/14/2018
• Initial Date FDA Received: 05/04/2018
• Supplement Dates Manufacturer Received: 08/21/2018
• Supplement Dates FDA Received: 08/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Disability