MAUDE Adverse Event Report: AESCULAP AG VARADY VARIX EXTRACTOR W/CATCH 180MM; GENERAL SURGICAL INSTRUMENTS

Model Number FB122R

Device Problems Break (1069); Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: date of event: unknown.Date of implant: unknown.Date of explant: unknown.Pending further information.

Event Description

It was reported by the healthcare professional to the company sales representative "one of the hooks was broken during a procedure and the broken piece went missing as well.".

Manufacturer Narrative

Investigation: the investigation was carried out visually and microscopically with a keyence vhx-5000 digital microscope and a panasonic dmc tz8 digital camera.We made a visual inspection of the instrument.Here we found and unknown etching.Additionally we detected a broken off tip and a quirk with a groove.Furthermore we made a visual inspection of the fracture surface.Here we found brown discoloration and unknown impurities.Batch history review: the device quality and manufacturing history records have been checked for the lot number and found to be according to the specificaiton, valid at the time of production.No similar incidents have been filed with products from this batch.Conclusion and root cause: the root cause fo the problem is most probably usage related.Rationale: according to the quality standard and dhr files, a material defect or production error can be excluded.No pores could be found on the point of rupture.There is the possibility of pre-damage or similar due to previous surgeries.Investigations lead to the assumption that the breakage and quirk with the groove were caused by an improper handling due to a mechanical overload situation.There is the possibility of high leverage with the instrument.We assume that the discoloration is unknown residues.No capa is necessary.Additional data: added.

• Brand Name: VARADY VARIX EXTRACTOR W/CATCH 180MM
• Type of Device: GENERAL SURGICAL INSTRUMENTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 7839761
• MDR Text Key: 119055434
• Report Number: 9610612-2018-00381
• Device Sequence Number: 1
• Product Code: HWB
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 10/31/2018

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: FB122R
• Device Catalogue Number: FB122R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2018
• Distributor Facility Aware Date: 08/06/2018
• Device Age: 4 YR
• Initial Date Manufacturer Received: 08/02/2018
• Initial Date FDA Received: 08/31/2018
• Supplement Dates Manufacturer Received: 10/18/2018
• Supplement Dates FDA Received: 10/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1