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

Catalog Number 0620050050

Device Problems Device Operates Differently Than Expected (2913); Improper Device Output (2953)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/17/2017

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.(b)(4).

Event Description

It was reported that during surgery, the concentration for co2 on the insufflator was running higher than normal.The surgeon had to convert from a lap procedure to open surgery.The procedure was completed successfully.

Manufacturer Narrative

(b)(4).The device manufacture date is not known.This insufflator was not received for evaluation at stryker endoscopy.This insufflator was received at oem-wom for evaluation.The reported failure "co2 running higher than normal for patient" cannot be confirmed.Alleged failure: co2 running higher than normal for patient probable root cause: the reported event could be not confirmed.There are no indications for a manufacturing issue.Increasing co2-levels are a clinical known side effect of co2-insufflation.Active ventilation of the patient helps to control and reduce the co2-level very well.Certain conditions have a negative effect on the co2-level and need to be considered during the procedure.E.G.Higher abdominal pressure, head down positioning, poor · patient relaxation, extra peritoneal insufflation (e.G.Hernia surgeries), reduced pulmonary function can promote high co2- levels.Investigation conclusion: the results of the investigation performed indicated that the returned pneumoclear plus co2 conditioning insufflator, catalog#0620050000 sn (b)(4) is working according to specification.The product was returned for investigation and the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.

Event Description

It was reported that during surgery, the concentration for co2 on the insufflator was running higher than normal.The surgeon had to convert from a lap procedure to open surgery.The procedure was completed successfully.

• Brand Name: PNEUMOCLEAR CO2 CONDITIONING INSUFFLATOR (AMERICAS)
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: ashley lower ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 7115183
• MDR Text Key: 94789122
• Report Number: 0002936485-2017-01205
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170784
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/13/2018

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: 0620050050
• Device Lot Number: 1707CE0035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/17/2017
• Initial Date FDA Received: 12/13/2017
• Supplement Dates Manufacturer Received: 11/17/2017
• Supplement Dates FDA Received: 06/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other