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

Model Number	PL049R
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to aesculap inc.That a atr.Grasper double action 420mm (part # pl049r) was used during a gynecologic laparoscopy procedure performed on (b)(6) 2022.According to the complainant, during the procedure, the laparoscopic grasper broke and a fragment detached into the patient.The broken piece was retrieved from the patient, and then the procedure was continued without further issue.The complaint device has not been returned to the manufacturer for evaluation.No patient injury was reported as a result of this event.
Additional Manufacturer Narrative
Uf/importer report # (b)(4).Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
Investigation complete.
Additional Manufacturer Narrative
Manufacturing site evaluation: the device was not returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation of the unit was performed and no parts were returned for failure analysis.Therefore, the investigation was not able to confirm a device issue that could be associated with the reported event.Due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

• 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
• MDR Report Key: 15546321
• Report Number: 2916714-2022-00105
• Device Sequence Number: 5684645
• Product Code: GEI
• UDI-Device Identifier: 04038653335695
• UDI-Public: 4038653335695
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2023
• Report Date (Section F): 10/05/2022

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: PL049R
• Device Catalogue Number: PL049R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/16/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/16/2022
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/05/2022
• Supplement Report FDA Received Date: 04/14/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR
• Patient Sex: Female
• Date Report Sent to FDA: 10/05/2022