MAUDE Adverse Event Report: AESCULAP AG AESCULAP SURGICAL INSTRUMENTS GENERAL SURGICAL INSTRUMENTS

Model Number AESCULAP010

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 12/08/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation: no product is at hand. Conclusion and root cause: based on the information available, the root cause of the failure is most probably related to an insufficient usage or maintenance of the device. Rational: based on the quality standards we exclude a material or manufacturer caused error. No capa is necessary.

Manufacturer Narrative

(b)(4). Manufacturing site evaluation: evaluation on-going. Device not returned.

Event Description

Country of complaint: usa. Neurosurgeon was using the number three kerrison instrument during a surgical procedure, a screw came loose on the kerrison and fell into the spinal cord. Neurosurgeon had to dig around in the opening with the suction and cst used a forcep to quickly grab it before it went into the neptune. No harm was done to the patient and instrument was reported.

• Brand Name: AESCULAP SURGICAL INSTRUMENTS
• Type of Device: GENERAL SURGICAL 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 ; 3145515988
• MDR Report Key: 7219320
• MDR Text Key: 272302726
• Report Number: 2916714-2018-00003
• Device Sequence Number: 1
• Product Code: HAE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: AESCULAP010
• Device Catalogue Number: AESCULAP010
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Distributor Facility Aware Date: 01/22/2018
• Event Location: No Information
• Date Manufacturer Received: 01/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 01/25/2018 Patient Sequence Number: 1