MAUDE Adverse Event Report: AESCULAP AG HF COMBI UNIT 300W MONOP.80W.BIPOLAR; ENDOSCOPY

Model Number GN300

Device Problem Thermal Decomposition of Device (1071)

Patient Problem 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 device had extreme burning issues.

Manufacturer Narrative

We sent the device to the generator manufacturing for analysis.They tested the device at the end of line test and compared the results with the archived eol test results of this serial number before delivery.During the performance test, the generator is connected with different dummy loads at the output and it has to work with different supply voltages.The number of generators per batch is one.The eol test files are within specification.The root cause for the problem is most probably user related.The complaint rf generator has past all tests (power, resistance, safety) without any deviation.According to (b)(4) there is no capa necessary.

• Brand Name: HF COMBI UNIT 300W MONOP.80W.BIPOLAR
• Type of Device: ENDOSCOPY
• 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: 6437603
• MDR Text Key: 71213483
• Report Number: 9610612-2017-00151
• Device Sequence Number: 1
• Product Code: KPZ
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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: 06/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GN300
• Device Catalogue Number: GN300
• Device Lot Number: 52187002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2017
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 03/09/2017
• Device Age: 15 MO
• Date Manufacturer Received: 02/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other