MAUDE Adverse Event Report: KLS MARTIN GMBH + CO. KG CE200 ELECTROSURGICAL UNIT; ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES

Catalog Number	CE200
Health Effect - Clinical Codes	Abdominal Distention (2601); Bowel Perforation (2668)
Date of Event	01/31/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
Device not returned, but evaluated by distributor.
Event or Problem Description
As reported by the user facility, on (b)(6) 2017, the surgeon used the ce200 electrosurgical unit (esu) in combination with argon beamer cb200 for treatment of extensive angiodysplasia of the right-side colon.The procedure was completed as planned.The patient experienced post-operative distension of the colon and a "perforated bowel".The surgeon stated that "he believed that the esu ce200 electrosurgical unit in use at the time, was set on the correct "argon right colon 30w" setting." to date no further information has been received regarding any medical or surgical intervention performed for this reported injury, nor the patient's current status.All information regarding this complaint has been forwarded from the manufacturer's dealer in (b)(4).The reported complaint issue was evaluated by the manufacturer's complaint procedure.The involved device was investigated by (b)(4) and was found to lie within its specification.The reported settings are okay and within the recommended range.In the performed procedure, a perforation is a known complication.
Additional Manufacturer Narrative
Additional information has been received by the user facility on march 31, 2017 advising "patient receiving treatment for angiodysplasia during a colonoscopy unfortunately received a cautery type burn injury/perforation of the caecum.The perforation was not picked up until 12 hours later and by this stage, patient had developed a faecal peritonitis/sepsis and went back to the theatre for repair.Patient deteriorated and died 4 days later." additional evaluation performed: the conclusion is that the surgeon used atypical (long) esu activations in the right colon, where shorter applications would be more typical, which may have led to the observed perforation.Specific details of the evaluation findings which were able to be determined following receipt of this additional customer information are as follows: confirmation of the date and time of surgery ((b)(6) 2017, early pm) allowed review of the service report data, including every pedal activation of the beamer esu system during surgery - the esu and associated components were evaluated in conjunction with the manufacturer.Unfortunately, the conmed a-beam-3 probe in use at the time was not returned for evaluation.The ce200 (esu), cb200 (argon unit) and two cables were evaluated in accordance with inspection procedure (b)(4) and subjected to a series of electrical tests in accordance with (b)(4).The devices and associated cables passed all tests.No fault was found and following consultation with the manufacturer, it was agreed that no further tests were necessary and that the products could be returned to the customer facility.There were 2 surgeries (series of activations) recorded on (b)(6) 2017 "pm": 1:40pm - 2:02pm and 3:57pm - 4:11pm.Both sets of activations indicated that there were no error messages; the only mode used was argon fast 30w (an acceptable setting for use in the caecum area); only channel mocoag2 (2nd monopolar channel) was used (this is similarly acceptable).Surgery (b)(6) 2017, 1:40pm - 2:02pm: it is most likely that this data set reflects the surgical procedure in question ("early pm").Activation ranged up to 28 seconds and the overall activation time was 4.5 minutes.This would be untypical of usage expected in a right colon application.Surgery (b)(6) 2017, 3:57pm - 4:11pm: activation ranged up to 29 seconds and the overall activation time was 3.5 minutes.Whilst the first 66 activations were typical, subsequent activations are untypical (long) in the final third of the procedure.If this was the result for surgery in the rectum, it may be acceptable (although not state-of-the-art), but again would be untypical of usage expected in a right colon application.Whilst there is no rule per se on how long a pedal might be activated, activation durations longer than 8-10 seconds may be atypical in any procedure.Right colon activation is typically spot wise rather than continuous, with a spot activation of 1 second or so.Longer activation durations (so called painting technique) of 5 seconds or so are not typical for right colon application.Spot wise application allows the user to inspect the target tissue from time to time.The bowel wall in the right colon is thin and typically these applications need to be performed with care.The beamer esu user manual provides several warnings including "warning! hazardous electrical output.This equipment is for use only by trained, licensed physicians.Do not use electrosurgical equipment unless properly trained to use it in the specific procedure being undertaken.Use of this equipment without such training can result in serious, unintended patient injury".An initial trial request for this user facility was dated (b)(6) 2014 and a sponsor representative and national product manager travelled to the user facility to complete in-service training with the num and staff of the gi department.More recently, a second beamer system trial was conducted with the surgeon on (b)(6) 2016 and a further in-service was conducted (b)(6) 2016, with the num and other key nursing staff.Additional in servicing was conducted (b)(6) 2016 (for the 2ic to the num) and again on (b)(6) 2017 (nursing staff attended) and (b)(6) 2016 (nursing staff attended).Following this adverse event, the surgeon contacted the sponsor representative on (b)(6) 2017 to discuss argon program settings on the beamer system.The representative and national product manager met with the surgeon on (b)(6) 2017 to discuss settings and argon therapy principles.

• Brand Name: CE200 ELECTROSURGICAL UNIT
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES
• Manufacturer (Section D): KLS MARTIN GMBH + CO. KG; am flughafen 18; freiburg 79108 ; GM 79108
• MDR Report Key: 6384003
• Report Number: 9681383-2017-00001
• Device Sequence Number: 16333608
• Product Code: GEI
• UDI-Device Identifier: 04057607000106
• UDI-Public: 04057607000106
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K081678
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2017

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
• Operator of Device: Physician
• Device Catalogue Number: CE200
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/09/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/07/2017
• Supplement Report FDA Received Date: 04/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CB200 BEAMER PLUS; CONMED ARGON PROBE A-BEAM-3
• Outcome Attributed to Adverse Event: Death; Other
• Patient Age: 78 YR