MAUDE Adverse Event Report: AESCULAP AG BIPOL.FORCEPS AAG FL.BAYO.F.1.0MM 200MM; BIPOLAR COAGULATION

Model Number GK616R

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 10/22/2021

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with gk616r - bipol.Forceps (b)(4) fl.Bayo.F.1.0mm 200mm.According to the complaint description, there was a burn in the mouth of the patient.There was temporary impairment of the patient.Additional information has been requested but not yet received as of this report.Additional patient information is not available.The malfunction is filed under (b)(4).

Manufacturer Narrative

Correction / additional information: e1: district.H6: codes.Investigation results: as of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.Batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.In the event that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.Based upon the investigations results a capa is not necessary.

• Brand Name: BIPOL.FORCEPS AAG FL.BAYO.F.1.0MM 200MM
• Type of Device: BIPOLAR COAGULATION
• 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: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 13125306
• MDR Text Key: 285257316
• Report Number: 9610612-2021-00807
• Device Sequence Number: 1
• Product Code: FSM
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K770428
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GK616R
• Device Catalogue Number: GK616R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1