LAPAROSCOPIC DEVICES

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-29 for LAPAROSCOPIC DEVICES manufactured by Aesculap Ag.

Event Text Entries

[50805801] (b)(4). Manufacturing site investigation: on-going.
Patient Sequence No: 1, Text Type: N, H10


[50805802] 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.
Patient Sequence No: 1, Text Type: D, B5


[62721419] 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.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3005673311-2016-00118
MDR Report Key5834931
Date Received2016-07-29
Date of Report2016-12-16
Date of Event2016-06-24
Date Facility Aware2016-06-30
Date Mfgr Received2016-06-30
Date Added to Maude2016-07-29
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag0
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Manufacturer ContactMS. NICOLE BROYLES
Manufacturer Street615 LAMBERT POINTE DRIVE
Manufacturer CityHAZELWOOD MO 63042
Manufacturer CountryUS
Manufacturer Postal63042
Manufacturer Phone3145515988
Manufacturer G1AESCULAP AG
Manufacturer StreetPO BOX 40
Manufacturer CityTUTTLINGEN, 78501
Manufacturer CountryGM
Manufacturer Postal Code78501
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Generic NameLAPAROSCOPIC DEVICES
Product CodeFDE
Date Received2016-07-29
Device Availability*
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerAESCULAP AG
Manufacturer AddressPO BOX 40 TUTTLINGEN, 78501 GM 78501


Patients

Patient NumberTreatmentOutcomeDate
101. Death 2016-07-29

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