MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PNEUMOCLEAR PLUS CO2 CONDITIONING INSUFFLATOR (AMERICAS); INSUFFLATOR, LAPAROSCOPIC

Model Number FM300

Device Problems Nonstandard Device (1420); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bradycardia (1751); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/11/2019

Event Type  Injury  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.

Event Description

It was reported that the patient experienced slowed heart rate resulting in the need for medical intervention to return heart rate to normal.

Event Description

It was reported that the patient experienced slowed heart rate resulting in the need for medical intervention to return heart rate to normal.

Manufacturer Narrative

Product was sent to oem - wom for investigation.Three attempts have been made to retrieve the oem's investigation report and it has yet to be received.In the event that the report is received, the report will be attached to the communication log.Alleged failure: patient's heart rate slowed.Probable root cause: because the oem's investigation report was not provided by oem - wom, probable root cause cannot be determined.The reported failure mode will be monitored for future re-occurrence.

Event Description

It was reported that the patient experienced slowed heart rate resulting in the need for medical intervention to return heart rate to normal.

Manufacturer Narrative

This device was received at oem-wom for evaluation.Based on the oem-wom investigation report attached, the reported failure ¿patient's heart rate slowed¿ was not confirmed.According to wom: visual inspection the devices were received on jan 3, 2020 for evaluation.There are no indications of transport damage or misuse.Functional inspection functional inspection based on the final test instruction indicated the returned device passed most criteria.Initial self-check passed; no errors occurred.Full functional testing was conducted, and some issues identified, all failed tests that were not passed were borderline: (b)(6).Unit passed all the testing, except for the hpu output pressure: hpu output pressure: 2.5 bar permissible tolerance: 2.0 bar ± 0.1 bar (b)(6).Unit passed all the testing, except for the following tests: hpu output pressure: 2.4 bar permissible tolerance: 2.0 bar ± 0.1 bar flow test at 20 l: 22.8 l/min permissible tolerance 20 l/min ± 2.6 l/min suction flow test at level 3: 10.1 l/min permissible tolerance 9 l/min +- 1 l/min) dimensional inspection due to the nature of the reported event, the dimensional inspection was deemed unnecessary and therefore not performed.Investigation conclusion the results of the investigation performed indicated that the returned pneumoclear plus co2 conditioning insufflator, catalog#0620050000 rev u, sn (b)(6) and sn (b)(6) are working according to specification.Probable root cause: the devices have been returned and evaluated by wom's technical service department.The output pressure of the high-pressure unit (hpu) of both units exceeded the permissible tolerance, however, there is an additional pressure reduction by the low-pressure unit (lpu) connected downstream of the hpu.The lpu further reduces the pressure so that ultimately the pressure preset by the or staff is achieved.The lpu test was passed as well as the test for the low-pressure safety valve (lsv).Therefore, the higher hpu output pressure is not critical for the patient and cannot be the root cause for the reported events (low heart rate and giving medication to restore normal cardiac rhythm/cardiac arrest).In addition to the higher hpu output pressure, unit (b)(6) also exceeded tolerances during the flow test and the suction flow tests.As the flow is only secondary to the pressure and a slight increased inflow performance will not contribute to a permanent overpressure in the cavity, these issues can be excluded as a contributor to the root cause as well.A slight increased suction flow will not contribute to permanent overpressure in the cavity as its purpose is to remove gas from the cavity.It is known that during laparoscopic procedures a low heart rate can occur, depending on the selected pressure and pre-existing conditions of the patient.Heart and cardiovascular parameters need to be monitored by the anesthesiologist over the entire course of the surgery, so that the or team can react accordingly.The most probable root cause is therefore either usage of an unsuitable pressure for the respective patient or a pre-existing condition with the patient leading to these complications.The reported failure mode will be monitored for future reoccurrence.Please note the manufacturing date is unknown.

• Brand Name: PNEUMOCLEAR PLUS CO2 CONDITIONING INSUFFLATOR (AMERICAS)
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 9555867
• MDR Text Key: 173889143
• Report Number: 0002936485-2020-00003
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04056702001308
• UDI-Public: 04056702001308
• Combination Product (y/n): N
• PMA/PMN Number: K170784
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FM300
• Device Catalogue Number: 0620050000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2019
• Date Manufacturer Received: 12/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other