MAUDE Adverse Event Report: AESCULAP AG CHALLENGER TI-P HANDLE; LIGATION / VESSEL CLIPS

Device Problems Material Separation (1562); Separation Problem (4043)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/27/2019

Event Type  malfunction  

Manufacturer Narrative

When new information becomes available a follow up report will be submitted.

Event Description

It was reported a challenger ti-p handle was broken.The challenger handle breaks in the same place.It is unknown which applier was being used with this handle since they are interchangeable.The component that is broken is the latch that holds the cartridge (co2 cylinder) in place.This incident did not cause or contribute to serious injury or death or a delay in surgery.No other information has been provided.

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 handle.Here we found a cracked cap.Additionally we detected a lost connection between the cap and the knee lever.Furthermore we made an optical inspection of the cap.Here we found broken off areas and a crack.We also made a visual inspection of the fracture surface.No abnormalities were found.We detected white discoloration at the inner hole of the cartridge adapter.Batch history review: the device quality and manufacturing history records have been checked for the lot number and found to be according to the specification, valid at the time of production.No similar incidents have been filed with products from this batch.Conclusion and root cause: the root cause of the problem is most probably reprocessing related.Rationale: according to the quality standard and dhr files, a production error and a material defect can be excluded.No inclusions or foreign bodies could be found on the point of rupture.According to the manager of plastic technology, the holes and cavities come from the shrinking process during the cooling phase during injection process.This is therefore no production error.Investigations lead to the assumption that the breakage and crack was caused by an improper reprocessing.We assume that the cartridge has not been removed for the reprocessing procedure.Additionally this assumption was confirmed by r&d maintenance implants platforms.Furthermore the white discoloration is an additional signs of a not removed cartridge during the reprocessing procedure.No capa is necessary.

• Brand Name: CHALLENGER TI-P HANDLE
• Type of Device: LIGATION / VESSEL CLIPS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 8456164
• MDR Text Key: 140003121
• Report Number: 9610612-2019-00220
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• PMA/PMN Number: K081031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/05/2019
• Date Manufacturer Received: 04/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1