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

Catalog Number 72203994

Device Problem Inflation Problem (1310)

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

Event Date 03/13/2019

Event Type  malfunction  

Event Description

It was reported that during an unknown procedure the device over-inflate, the pressure went above setting.The procedure was completed with a backup device with no delay or patient injury reported.

Manufacturer Narrative

The device was received and shipped to the oem (original equipment manufacturer) for evaluation.There was no relationship found between the returned device and the reported incident.A visual inspection was performed by the oem and found that the bezel, upper left corner, and both left and right bottom corners were cracked.The bulkhead seal to hose connection was damaged.A functional evaluation was performed by the original equipment manufacturer.The unit was tested for proper operation and performed as expected.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.An oem review of the device history records show there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.The user can reference the operations/service manual, for information regarding reducing the likelihood of potential over-pressure situations which includes the use of the smith & nephew 500 insufflator tap¿ feature and the associated tap¿ tubing set as often as possible.Do not use any other tubing set for this purpose as it may directly affect the pressure monitoring results.

• 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
• MDR Report Key: 8496266
• MDR Text Key: 141446595
• Report Number: 1643264-2019-00262
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 03596010673497
• UDI-Public: 03596010673497
• Combination Product (y/n): N
• PMA/PMN Number: K120151
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 07/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2019
• 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: 03/30/2019
• Date Manufacturer Received: 07/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1