MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CONTROL UNIT 400 INSUFFLATOR S&N; INSUFFLATOR, LAPAROSCOPIC

Catalog Number 7209931

Device Problem Insufficient Information (3190)

Patient Problems Inflammation (1932); Swelling (2091); Tissue Damage (2104); Complaint, Ill-Defined (2331); Test Result (2695)

Event Date 01/01/2011

Event Type  Injury  

Manufacturer Narrative

(b)(6).(b)(4).

Event Description

It was reported per a literature review that during an evh procedure, co2 infiltration occurred through the deep inguinal ring and into the scrotum leading to acute scrotal enlargement.Due to the risk of impediment of vascular blood supply and necrosis, endoscopic vein harvesting was withdrawn, and the vein was harvested by using the bridging technique.On postoperative day 3, vesicular eruption of skin blisters along the shaft of the penis, scrotum, and leg was noted.Repeated microbiology reports were negative, but the leg was very inflamed, swollen, and the d-dimer test was positive.The patient commenced two different courses of antibiotics for a 14-day period.Fourteen days postoperatively, swelling decreased and the patient noted improvement in symptoms; he was discharged home.

Manufacturer Narrative

No additional relevant clinical supporting details were made available, thus a thorough medical assessment could not be performed by our clinical investigation team.The reported device was not made available to the designated complaint unit for evaluation, thus a visual inspection and functional testing could not be performed.The serial number of the devices used was not identified and thus a review of manufacturing records could not be conducted.A review of the complaint history record for the 400 insufflator, p/n 7209931, found no similar events in the 12 months prior to the journal publication date.The operations and service manual (p/n 1061349) for the smith & nephew 400 insufflator was reviewed and identifies the following indications and contraindications related to the proper use of the device relevant to the complaint event: the smith & nephew 400 insufflator is indicated for use for gas distension of the abdomen for diagnostic and/or operative laparoscopy.The smith & nephew 400 insufflator should be used only for laparoscopic procedures and should not be used for any other treatments.The use of the 400 insufflator is contraindicated for use in the procedure performed on this patient.Therefore, the use of the 400 insufflator for this particular procedure is considered to be off label.

• Brand Name: CONTROL UNIT 400 INSUFFLATOR S&N
• 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: james gonzales ; 150 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 5966935
• MDR Text Key: 55264329
• Report Number: 1643264-2016-00171
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K022052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/24/2016

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: 7209931
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/24/2016
• Initial Date FDA Received: 09/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/21/2016
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR