MAUDE Adverse Event Report: AESCULAP AG CAIMAN DISP.INSTR.NON ARTICUL.D5/360MM; SEAL & CUT INSTRUMENTS

Model Number PL740SU

Device Problems Failure to Conduct (1114); Device Operates Differently Than Expected (2913)

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

Event Date 02/08/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: there is a clear visible charring at the right side of the upper jaw.A visual inspection of the jaw was performed.Except the charring no further abnormities was found.Then the mechanical functions we checked.The clamping and the cutting function worked well.The manufacturing documents have been checked and found to be according to specification which was valid during the time of the production.One probable root cause in cases like this is a not a proper cleaning during surgery, so the carbonized residues of blood or tissue initiate are arc.A further possible root cause is a damaged insulation tongue (dissection clip).This damage created by wrong handling during cleaning the electrodes.A damage during the rf-generator failures can be excluded.There is suspicion of a design related aspect to the failure, this failure mode has been into a capa.

Event Description

Country of complaint: (b)(6).It was reported that the caiman stops working after a short time of use.No surgery delay occurred.

• Brand Name: CAIMAN DISP.INSTR.NON ARTICUL.D5/360MM
• Type of Device: SEAL & CUT INSTRUMENTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042
• MDR Report Key: 7660546
• MDR Text Key: 113186261
• Report Number: 9610612-2018-00314
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K151696
• 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
• Report Date: 07/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: PL740SU
• Device Catalogue Number: PL740SU
• Device Lot Number: 52393218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2018
• Distributor Facility Aware Date: 03/16/2018
• Device Age: 7 MO
• Date Manufacturer Received: 02/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other