MAUDE Adverse Event Report: AESCULAP AG SHAFT COMPL.D:5MM L:310MM; LAPAROSCOPIC SURGERY

Model Number PL522R

Device Problem Compatibility Problem (2960)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 04/15/2020

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: 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 shaft.It was reported that the tip of the jaw was closed and did not open after clipping into the blood vessel during intraoperative abdominal operation.To recover, removed the blood vessel and the jaw from the trocar.After hemostasis operation, another pl604r product was opened and the operation was restarted.When the pl572t and pl575su were set on the actual sample at the site and the operation was checked, it was judged that the operation of the tip of jaw was smooth and there seemed to be no problem.On the other hand, after clipping to the silicon tube, the phenomenon that the next clip filling did not work well and dropped from the jaw was reproduced.When the tip of jaw was confirmed with a magnifying glass, it was visually confirmed that the tip of jaw was slightly expanded to the outside.The patient have no infections.Additional information received with the date of awareness (b)(6) 2020: confirmation that 400470177 and 400470189 with pl604r clip applier occurred during same surgery.No duplicate.The surgeon tried two pl604 clip applier.Only after third applier the surgery could continued.Further request about extent of bleeding, loss of blood and method of hemostasis, surgery delay and complete surgery time was made.Information pending.Additional information received with the date of awareness (b)(6) 2020: "the vessel where clip was applied is a portal canal (glisson's sheath) of approximately 1-3mm in diameter.Bleeding occurred to a small vessel and hemostasis was done using a ball electrode.Hemostasis was successfully done only using an electrode and there was not change in vital signs as a result of bleeding.Although extent of bleeding was miniscule, it is not known how much.As for surgical delay, it is not known exactly how long, but it was reportedly within 15 min." the adverse event/malfunction is filed under aag refernece (b)(4).Associated medwatch-reports: 400470177 (9610612-2020-00160 pl522r).400470189 (9610612-2020-00163 pl522r).

Manufacturer Narrative

New information updated: -batch number d4; -manufacturing date h4.Associated medwatch-reports: (b)(4) (9610612-2020-00160 pl522r); (b)(4) (9610612-2020-00163 pl522r).Manufacturing site evaluation: investigation still on-going.Additional information / investigation results will be provided in a supplemental report.

Manufacturer Narrative

Associated medwatch-reports: 400470177 (9610612-2020-00160 pl522r).400470189 (9610612-2020-00163 pl522r).Investigation results: two appliers were provided for investigation, but neither the clip cartridges not the co2 cartridge were sent for investigation.The provided appliers are in a good condition, no visual deviations can be found.A functional test was carried out using a cartridge from stock successfully.The devices were sent to the production plant for further investigations.The investigation results will be submitted in a supplemental report as soon as the results are available.A functional test was carried out successfully, no malfunction could be detected.The failure mentioned could be caused by an improper montage of the cartridge used.Nevertheless, further investigations are ongoing, this report will be updated as soon as the results are available.A capa is not necessary.

Manufacturer Narrative

This supplemental report is being re-submitted as #3; #2 failed as a duplicate in webtrader.Associated medwatch-reports: 400470177 (9610612-2020-00160 pl522r) 400470189 (9610612-2020-00163 pl522r) investigation results: two appliers were provided for investigation, but neither the clip cartridges not the co2 cartridge were sent for investigation.The provided appliers are in a good condition, no visual deviations can be found.A functional test was carried out using a cartridge from stock successfully.The devices were sent to the production plant for further investigations.The investigation results will be submitted in a supplemental report as soon as the results are available.A functional test was carried out successfully, no malfunction could be detected.The failure mentioned could be caused by an improper montage of the cartridge used.Nevertheless, further investigations are ongoing, this report will be updated as soon as the results are available.A capa is not necessary.

Manufacturer Narrative

Associated medwatch-reports: 400470177 (9610612-2020-00160 pl522r); 400470189 (9610612-2020-00163 pl522r).Investigation results: further investigation and measurements4 have been carried out by the responsible q-coordinator of the production plant: the jaw parts are bent and impact marks can be found at the clip guiding rail.The handle passed the functional test successfully.Functional test passed.The device quality and manufacturing history records (dhr) have been checked for all available lot numbers and the products found to be according to our specification valid at the time of production.There are no similar complaints against the same lot number with this error pattern.Due to the deviation at the jaw of shaft form, a proper function is not longer guaranteed.We assume improper handling during application or reprocessing.A capa was not initiated.

• Brand Name: SHAFT COMPL.D:5MM L:310MM
• Type of Device: LAPAROSCOPIC SURGERY
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10058102
• MDR Text Key: 191542742
• Report Number: 9610612-2020-00160
• 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,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PL522R
• Device Catalogue Number: PL522R
• Device Lot Number: 62335652
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2020
• Date Manufacturer Received: 09/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PL572T; PL572T; PL572T; PL574T; PL574T; PL574T; PL575SU; PL575SU; PL575SU
• Patient Outcome(s): Required Intervention