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

Model Number FM300

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Scar Tissue (2060)

Event Date 11/07/2019

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 aborted.The surgeon attributed this to excessive scar tissue.

Event Description

It was reported that the procedure was aborted.The surgeon attributed this to excessive scar tissue.

Manufacturer Narrative

This device was received at oem-wom for evaluation.Based on the oem-wom investigation report attached, the reported failure ¿excessive scar tissue¿ was not confirmed.According to wom: visual inspection.The device was received on nov 15, 2019 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 all criteria.Initial self-check passed; no errors occurred.Regarding the complaint, pressure testing was performed with lap dummy at 15, 20, 30mmhg, and was always found to be stable, no fluctuations occurred.Pressure sensor test was also performed.According to the final test instructions at 5, 15, and 30mmhg, and was also found to be within specifications.Dimensional inspection.Due to the nature of the reported event, the dimensional inspection was deemed unnecessary and therefore not performed.The results of the investigation performed indicated that the returned pneumoclear plus.Co2 conditioning insufflator, catalog#0620050000 rev u, sn (b)(6).Working according to specification probable root cause: the reported event could be not confirmed.There are no indications of a manufacturing issue.The reported failure mode will be monitored for future reoccurrence.

• 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: 9399163
• MDR Text Key: 168773962
• Report Number: 0002936485-2019-00532
• 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
• Report Date: 02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2019
• 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: 11/15/2019
• Date Manufacturer Received: 11/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other