MAUDE Adverse Event Report: AESCULAP AG DS-SINGLE FIRE LAP.APPLIER SM 5/310MM; LIGATION / VESSEL CLIPS

Model Number PL802R

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

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 pl802r - ds-single fire lap.Applier sm 5/310mm.According to the complaint description, the application portion fell into the patient's body the applicator portion was about 7mm in diameter, and had protruded from near the jaw.The procedure included thoracic access in order to place 2 clips on the sympathetic nerve in order to treat hyperhidrosis.The piece fell into the retro-pulmonary area that was not accessible and therefore was unable to be recovered.An additional medical intervention was necessary.There was a surgical delay of more than 15 minutes.Additional information has been requested.The adverse event is filed under aag reference (b)(4).

Manufacturer Narrative

Additional information: h6 - codes updated.Investigation: the complaint sample was not returned, thus a product investigation was not possible.Review of device history records: due to the fact that no lot number was provided, a review of the device history records as well as a batch-related complaint history review for the complaint device is not possible.Explanation and rationale: according to the quality standard a material defect and a production error can be excluded.Without the product available for investigation, we cannot determine a definitive root cause for the reported issue.If the device is returned in the future, another investigation will be performed.Conclusion and preventive measures: 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.Based upon the investigation results, a capa is not necessary.

• Brand Name: DS-SINGLE FIRE LAP.APPLIER SM 5/310MM
• Type of Device: LIGATION / VESSEL CLIPS
• 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 gruen ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 16523405
• MDR Text Key: 311084504
• Report Number: 9610612-2023-00048
• Device Sequence Number: 1
• Product Code: GDO
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: EXEMPT
• 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: 06/08/2023

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
• Device Operator: Health Professional
• Device Model Number: PL802R
• Device Catalogue Number: PL802R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/28/2023
• Initial Date FDA Received: 03/10/2023
• Supplement Dates Manufacturer Received: 05/26/2023
• Supplement Dates FDA Received: 06/08/2023
• 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
• Patient Outcome(s): Required Intervention