MAUDE Adverse Event Report: AESCULAP AG ATR.GRASPER DOUBLE ACTION 420MM; HANDHELD PRODUCTS & LIGATION

Model Number	4038653335695PL049R
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Additional information /investigation results will be provided in a supplemental report.
Event or Problem Description
It was reported to aesculap ag that an issue occurred with an atr.Grasper double action 420mm (part # pl049r) via information received from user facility mw (b)(4).According to the complainant, a piece of the grasper broke inside the patient.The piece was immediately identified and removed.This occurred during a laparoscopic gynecologic surgery.Patient was not further injured.An additional medical intervention was required.The adverse event /malfunction is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Additional information: h6 - codes updated 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.Explanation and rationale: unfortunately, due to a lack of data and without the product we cannot determine the exact root cause for the mentioned deviation.According to the quality standard, a production error and a material defect can most probably be excluded.If further investigations are required, the product should be provided for examination.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.Root cause cannot be finally concluded.Therefore the root cause specific risk cannot be identified.The potential risk determined during initial vigilance evaluation remains valid.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: ATR.GRASPER DOUBLE ACTION 420MM
• Common Device Name: HANDHELD PRODUCTS & LIGATION
• 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 grun ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 15539133
• Report Number: 9610612-2022-00286
• Device Sequence Number: 15215417
• Product Code: GEI
• UDI-Device Identifier: 04038653335695
• UDI-Public: 4038653335695
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K940936
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 4038653335695PL049R
• Device Catalogue Number: PL049R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2022
• Supplement Date Received by Manufacturer: 03/15/2023
• Initial Report FDA Received Date: 10/04/2022
• Supplement Report FDA Received Date: 04/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR
• Patient Sex: Female