MAUDE Adverse Event Report: AESCULAP AG CAIMAN DISP.INSTR.NON ARTICUL.D:5/360MM; SEAL & CUT INSTRUMENTS

Model Number PL720SU

Device Problem Unintended Electrical Shock (4018)

Patient Problem Electric Shock (2554)

Event Date 12/18/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).When additional information is received a follow up report will be submitted.

Event Description

It was reported by the healthcare professional "that after using the caiman for approximately 1 1/2 - 2 hours without any problems, the surgeon got an electric shock on her right hand.According to the staff the electric shock occurred from the handle of caiman.There was no hole in the gloves belonging to the surgeon.The incident occurred when the instrument was inside the abdomen and the surgeon closed the jaws.The surgeon does not know if she pressed the activation button or not when the shock occurred.It was reported that there was no delay in surgery.Additional information has been requested concerning the surgeon.If additional information is received a follow up report will be submitted.All med watch submissions related to this patient are: 9610612-2019-00014 (this report addresses the instrument); 9610612-2019-00015.Components in use listed as concomitant devices are: lektrafuse hf generator bipolar / gn200.

Manufacturer Narrative

The instrument exhibits no outwardly damage or failure.We investigated the mechanical functions.The clamping and cutting function are working correctly.Then we investigated the cable and the hosing / handle, especially the cable entry at the handle.Here we found no abnormities like broken edges or damaged insulation.In the next step we opened the handle to check the writing.The writing is correct, no wire was trapped between the housing shells.The manufacturing documents have been checked and found to be according to specification valid during the time of production.There are no further complaints with this lot at hand.The root causes for the problem is most probably usage related.The investigation of the insulation and the writing of the instrument showed no irregularities like damaged insulations or trapped/clamped cable or wires.Because caiman is a bipolar rf system, there is no potential to earth at the instrument, so an electrical shock caused by an insulation failure of one wire is impossible.The rf current flows only between the both electrodes.This is the big advantage over the monopolar system.Without further knowledge about the circumstances we assume, that the surgeon interpreted a hepatic feedback from the ratchet in the handle (part of the clamping mechanism) as a little electric shock.No capa neccessary.Associated med watch reports: 9610612-2019-00015.

• Brand Name: CAIMAN DISP.INSTR.NON ARTICUL.D:5/360MM
• Type of Device: SEAL & CUT INSTRUMENTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 8235339
• MDR Text Key: 132767328
• Report Number: 9610612-2019-00014
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K130596
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: PL720SU
• Device Catalogue Number: PL720SU
• Device Lot Number: 52468171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2019
• Distributor Facility Aware Date: 01/10/2019
• Device Age: 2 MO
• Date Manufacturer Received: 01/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LEKTRAFUSE HF GENERATOR BIPOLAR / GN200
• Patient Outcome(s): Other