MAUDE Adverse Event Report: AESCULAP AG; LAPAROSCOPIC DEVICES

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Hemorrhage/Bleeding (1888)

Event Date 06/24/2016

Event Type  Death  

Manufacturer Narrative

(b)(4).Manufacturing site investigation: on-going.

Event Description

Country of complaint: (b)(6).It has been reported that following a laparoscopic urology procedure in which the patient's spleen was penetrated, internal bleeding occurred resulting in death.It was noted that not all of the articles (medical devices) used to carry out the procedure were manufactured by aesculap (b)(4).Additional information including details regarding the incident and the devices used during procedure has been requested.A supplemental report will be submitted when information is received.Please note: as devices used are unknown, procode selection will be corrected when information is received.

Manufacturer Narrative

The equipment and instruments, used in the procedure, are in a good condition.The investigation was carried out by an employee of aesculap technical service chifa.Based on the information available as well as a result of our investigation the root cause of the failure is most probably user related.Pursuant to the decision of the district prosecutor in lask of (b)(6) 2016, (b)(6), an employee of aesculap ag, was appointed as ad hoc expert in connection with the incident that took place on (b)(6) 2016 during exploratory laparoscopy.The expert was appointed to issue an opinion on the technical state of equipment comprising the laparoscopy system and the accessories (instruments).On (b)(6) 2016, a review was carried out in the presence of the representatives of (b)(4), namely (b)(6) the review encompassed the equipment and instruments that were used in the aforementioned procedure.Firstly, the appointed employee from aesculap chifa carried out a selection of equipment and instruments dividing them according to manufacturer.Not all the articles used to carry out the procedure were manufactured by aesculap ag.In the course of further activities, products manufactured by aesculap ag were inspected.As a result of the activities related to the performance of a technical inspection in accordance with the manufacturer's requirements, it was concluded that all equipment and instruments are in good technical condition.The evaluation was carried out in the presence of the prosecutor's representatives, the second expert, (b)(6) and the representatives of the hospital: the head of the hospital and the nurse in charge of the operating theatre.The aforementioned individuals did not raise any objections concerning the evaluation itself or the results of the technical inspection.Additional measures ordered by the prosecutor included the assessment of the compatibility of the trocar- a device used and secured as evidence in the investigated case (only compatibility with the aesculap ag laparoscope), which was not manufactured by aesculap ag.The assessment confirmed the compatibility of the two devices.Based on the information obtained, an electrocoagulation device, not manufactured by aesculap ag, was also used in the course of the procedure.Please note, that the laparoscope was located in an unsecured hospital facility together with other hospital equipment, with potential third- party access.It is not certain that a device, and in this case which device, caused the failure.Thereby a statistical analysis can not be carried out.The failure is most probably user related and all the devices of aesculap ag are in are good condition corrective/preventive action is not required.

• Type of Device: LAPAROSCOPIC DEVICES
• 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 ; 3145515988
• MDR Report Key: 5834931
• MDR Text Key: 50805801
• Report Number: 3005673311-2016-00118
• Device Sequence Number: 1
• Product Code: FDE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Distributor Facility Aware Date: 06/30/2016
• Date Manufacturer Received: 06/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 3 YR