MAUDE Adverse Event Report: AESCULAP AG DISP.COMBINATION INSTR.BIPOLAR D:5/310MM; DISPOSABLE INSTRUMENTS

Model Number PO800SU

Device Problem Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/25/2021

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 po800su.According to the complaint description, the jaw could not be moved any more during surgery.A device for replacement has to be used, surgery was completed without further problems.This malfunction prolonged the surgery.Additional information was not provided nor available.Additional patient information is not available.The malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation results/ visual investigation: vigilance investigator carried out the pictorial documentation visually and microscopically.Large burr and chatter marks present on bicon.Shear no longer runs smoothly.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.Review of the complaint history revealed that no similar complaints have been filed against products from this batch number.Conclusion and measures / preventive measures: based on the investigation report, the root cause of the failure was usage related.Based upon the investigations results a capa is not necessary.

• Brand Name: DISP.COMBINATION INSTR.BIPOLAR D:5/310MM
• Type of Device: DISPOSABLE 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: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 12249402
• MDR Text Key: 264270308
• Report Number: 9610612-2021-00526
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K001330
• 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: 11/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PO800SU
• Device Catalogue Number: PO800SU
• Device Lot Number: 52679633
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2021
• 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