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

Catalog Number	72203994
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/14/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device did not cut off after set pressure was reached.The machine continuously pumped gas irrespective of pressure, due to which the abdomen pressure went extremely high.
Additional Manufacturer Narrative
The reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A relationship, if any, between the subject device and the reported event could not be determined.No containment or corrective actions are recommended at this time.A review of the device history record shows there are no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.
Additional Manufacturer Narrative
The device, a 72203994 - smith & nephew 500 insufflator serial number 90851jzc, 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.If new information related to this complaint is received, this evaluation will be reopened for investigation.

• Brand Name: SMITH & NEPHEW 500 INSUFFLATOR
• Common Device Name: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• MDR Report Key: 7489003
• Report Number: 1643264-2018-00338
• Device Sequence Number: 11141264
• Product Code: HIF
• UDI-Device Identifier: 03596010673497
• UDI-Public: (01)03596010673497
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K120151
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/17/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: 72203994
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2018
• Initial Date Received by Manufacturer: 04/14/2018
• Supplement Date Received by Manufacturer: 04/14/2018; 09/14/2018
• Initial Report FDA Received Date: 05/04/2018
• Supplement Report FDA Received Date: 06/20/2018; 09/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1