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

Catalog Number 72203994

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 12/12/2017

Event Type  malfunction  

Event Description

It was reported that the insufflator pressure read 40 and began a constant alarm.The insufflator was switched off and replaced immediately.No patient injury was reported.

Manufacturer Narrative

The device was received and sent to the oem (original equipment manufacturer) for further evaluation.There was no relationship found between the returned device and the reported incident.A visual inspection was performed on the product and a cracked front panel bezel was observed.The complaint was not confirmed as the reported malfunction was not observed during functional evaluation.Factors, unrelated to the manufacturing and design of the device which could have contributed to the reported event, include not using the direct pressure monitoring (via the tap tubing set) or blockage of the gas delivery line.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.

• 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: 7163487
• MDR Text Key: 96357073
• Report Number: 1643264-2018-00015
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K120151
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/10/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: 72203994
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/12/2017
• Initial Date FDA Received: 01/04/2018
• Supplement Dates Manufacturer Received: 04/03/2018
• Supplement Dates FDA Received: 04/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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