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

Model Number AESCULAP010

Device Problem Material Fragmentation (1261)

Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Country of complaint: (b)(6).It was reported that the tip broke off inside the patient.

Manufacturer Narrative

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

• 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: 7028704
• MDR Text Key: 93065586
• Report Number: 9610612-2017-00559
• Device Sequence Number: 1
• Product Code: KOA
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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,Followup
• Report Date: 01/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AESCULAP010
• Device Catalogue Number: AESCULAP010
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 11/10/2017
• Initial Date Manufacturer Received: 10/23/2017
• Initial Date FDA Received: 11/14/2017
• Supplement Dates Manufacturer Received: 10/23/2017
• Supplement Dates FDA Received: 01/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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