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

Catalog Number 0620050000

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 08/13/2018

Event Type  Injury  

Manufacturer Narrative

The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.Additional information will be provided once the investigation has been completed.

Event Description

It was reported that the procedure was converted to open surgery.

Event Description

It was reported that the procedure was converted to open surgery.

Manufacturer Narrative

Alleged failure: inconsistent pressure.Probable root cause: because device was not returned to oem - wom, probable root cause cannot be determined.The product was not returned for investigation; therefore, the reported failure mode was not confirmed.The reported failure mode will be monitored for future reoccurrence.The device manufacture date is not known.

Manufacturer Narrative

This insufflator was not received for evaluation at stryker endoscopy.This insufflator was received at oem-wom for evaluation.Based on the oem-wom service record attached, the reported failure ¿inconsistent pressure¿ was not confirmed.The reported failure mode will be monitored for future reoccurrence.According to wom: visual inspection - the device was received on sep 24, 2018 for evaluation.Device was shipped with the correct packaging and no shipping damages were found.The device is in poor condition, front panel is cracked, upper casing has many scratches.Functional inspection - initial self-check could not be conducted due to the power switch will not stay pressed (damaged front panel).Dimensional inspection - due to the nature of the reported event, the dimensional inspection was deemed unnecessary and therefore not performed.Full functional inspection could not be conducted initially.Front panel was replaced, the full functional testing was performed, and no failures were triggered.Unit was tested with lap dummy for several minutes at different pressure settings, and was found to be very stable, no abnormalities were detected.The results of the investigation performed indicated that the returned pneumoclear plus c02 conditioning insufflator, catalog#0620050000 rev p, sn (b)(4) is working according to specification.Probable root cause: is: the reported event could be not confirmed.There are no indications of a manufacturing issue.

Event Description

It was reported that the procedure was converted to open surgery.

• 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: 7862197
• MDR Text Key: 119782362
• Report Number: 0002936485-2018-00603
• 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: 05/15/2019

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 Catalogue Number: 0620050000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2018
• Initial Date Manufacturer Received: 08/13/2018
• Initial Date FDA Received: 09/10/2018
• Supplement Dates Manufacturer Received: 08/13/2018; 08/13/2018
• Supplement Dates FDA Received: 12/07/2018; 05/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other