MAUDE Adverse Event Report: AESCULAP AG DISP.TROCAR THRD.W.DILATING PIN 12/110MM; ACCESS / TROCARS

Model Number EK236SU

Device Problems Break (1069); Material Integrity Problem (2978)

Patient Problems Foreign Body In Patient (2687); Patient Problem/Medical Problem (2688)

Event Date 06/13/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported the valve on the seal was shredded.The reporter indicated that during a surgical procedure it was noticed that the valve on the seal was shredded and eventually fell into patient's body.The surgeon removed the fragment from the patient's body.Per the reporter, all fragments were removed.It was also reported that the physician mentioned that when he used ds clip, valves most likely damaged and changed ek002su a few times.Also, air tightness got worse after ds clip was used.The ds applier's jaws are open when it is inserted.Additional information has been requested, however, as of this report has not yet been received.

Manufacturer Narrative

Investigation we made a visual inspection of the sealing unit.Here we found a broken off fragment and unknown impurities.Additional we made an optical inspection of the locking ring ek002241 and cross slot valve ek002251.No visible damage but unknown impurities were also detected.Next we made a visual inspection of the shell ek002240 with universal converter k002250 and blinding-protector ek002252.Her we discovered visible damage and an unknown product.Furthermore we made a visual inspection of the ek02250 and universal converter.Her we found visible damage and the unknown product.We also made an optical inspection of the blinding-protector ek002252.Here we ground unknown impurities.Batch history review the device quality and manufacturing history records have been checked for the lot number (52502762) 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 usage related.Rationale according to the quality standard and dhr files a material defect and production error can b excluded.Investigations lead to the assumption that the visible damaged universal converter ek002250 was caused by an improper handling.It appears that the unknown product is a third-party product.Due to the third- party production there is the possibility for a malfunction due to an incompatible instrument.By insert the instrument the universal converter could has been damaged.Per the ifu caution must be observed as malfunction can occur due to incompatible instruments.No capa needed.

• Brand Name: DISP.TROCAR THRD.W.DILATING PIN 12/110MM
• Type of Device: ACCESS / TROCARS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 8772217
• MDR Text Key: 152113721
• Report Number: 9610612-2019-00450
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• PMA/PMN Number: K101937
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/18/2024
• Device Model Number: EK236SU
• Device Catalogue Number: EK236SU
• Device Lot Number: 52502762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2019
• Date Manufacturer Received: 08/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1