MAUDE Adverse Event Report: AESCULAP AG VARADY VARIX EXTRACTOR W/CATCH 180MM; GENERAL INSTR.CARDIOVASC.& THO

Model Number FB122R

Device Problem Detachment of Device or Device Component (2907)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that there was an issue with a unknown device manufactured by aesculap ag.According to the user facility report (b)(4) the tip of the medium crochet vein hook brook off into the patient on first pass.Staff surgeon immediately was aware and looked for piece at the surgical site and on the surgical field using both visual inspection and vascular ultrasound inspection.Surgical team searched the surgical field.Circulating nurse searched the operating room (or) floor visually and with a magnet broom.The tip of the crochet vein hook was not located.The article code of the device is unknown.The incident occurred on an unspecified day in (b)(6) 2020, during a right lower extremity great sapheanous venous ablation.An additional medical intervention was necessary.Additional information was not provided.Additional information has been requested but not yet received as of this report.Additional patient information is not available.The adverse event is filed under aag reference (b)(4).

Event Description

No updates.

Manufacturer Narrative

The product has been returned and is in transit to the second location (manufacturer), but the final evaluation has not yet been received.Reference code fb122r.Device name varady varix extractor w/catch 180mm.Serial number n/a.Batch number unknown.Udi device identifier (b)(4).Udi production identifier unknown.Basic udi-di (b)(4).Unit of use udi-di (b)(4).Manufacturing date unknown.Failure description - up to now, no product available.Batch history review - due to the fact that no lot number was provided, a review of the device history records remains incomplete.Explanation and rationale, conclusion - unfortunately due to 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.Corrective action - no capa necessary.

Event Description

The complainant reported an issue with an unknown device manufactured by aesculap ag.According to the user facility (uf report # (b)(4)), the tip of the medium crochet vein hook broke off into the patient on first pass.The staff surgeon was immediately aware of the issue and attempted to locate the piece at the surgical site and on the surgical field using both visual inspection and vascular ultrasound inspection.The surgical team searched the surgical field, and the circulating nurse searched the operating room (or) floor visually and with a magnetic broom, however, the tip of the crochet vein hook was not able to be located.The article code of the device is unknown.The incident occurred on an unspecified day in (b)(6) 2020, during a right lower extremity great saphenous venous ablation.An additional medical intervention was necessary.Although requested, no further patient and/or event information has been made available.Should additional details become available, a supplemental medwatch report will be submitted.The adverse event is filed under aag reference (b)(4).

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.An investigation of the device manufacturing records was not able to be conducted by the manufacturer as the model # and lot # of the device in question was not known.However, all device history records (dhr) are reviewed and released according to documented procedures and a device is not released if it does not meet requirements or is nonconforming.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

Manufacturer Narrative

D section: material updated.The product has been returned but the updated evaluation has not yet been received.

Event Description

No updates.

Event Description

No updates.

Manufacturer Narrative

Investigation results: reference code: (b)(4).Device name: varady varix extractor w/catch 180mm.Serial number: n/a.Batch number: unknown.Manufacturing date: unknown.Investigation: the investigation was carried out visually and microscopically with the digital microscope and the digital-camera.We made a visual inspection of the product and of the fracture surface.Here we found red brown discolorations and unknown impurities but no anomalies.For further investigation the current status and the deviation will be discussed with the expert r&d instruments & surfaces.Should the investigation reveal new evidence, leading to a different conclusion, this report will be adapted.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: according to the quality standard and dhr files a material defect and production error can be excluded.Investigations lead to the assumption that the broken off part could have caused by an overload situation during handling.The red brown discoloration could be rust.Probably, pre-cracks occurred during former applications and in the end, a forced fracture caused the fracture of the working end.Conclusion and root cause: the root cause of the problem is most probably usage-related.There is no capa necessary.

• Brand Name: VARADY VARIX EXTRACTOR W/CATCH 180MM
• Type of Device: GENERAL INSTR.CARDIOVASC.& THO
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10468688
• MDR Text Key: 205102409
• Report Number: 2916714-2020-00429
• Device Sequence Number: 1
• Product Code: DWS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/28/2020,02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FB122R
• Device Catalogue Number: FB122R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2020
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/28/2020
• Distributor Facility Aware Date: 11/09/2020
• Event Location: Hospital
• Date Report to Manufacturer: 07/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR