MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PNEUMO SURE INCL. MANUAL: EN; INSUFFLATOR, LAPAROSCOPIC

Catalog Number 620040601SSP

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

Patient Problems High Blood Pressure/ Hypertension (1908); Tachycardia (2095)

Event Date 10/28/2013

Event Type  malfunction  

Event Description

It was reported that the anaesthetist experienced problems during a laparoscopic cholecystectomy.Within the first two minutes, tachycardia and a fall in blood pressure was observed with low output.It was further reported that a severe hypotension out of proportion compared with the usual hypotension due to pneumoperitoneum.The company representative assumed that the patient was tied.Once the surgeon started the dissection no hemodynamic problems; very stable.The customer reports acute respiratory increase peak pressure 15mmhg, without cause, immediately afterwards co2 drop so again with acute drop in blood pressure of 130/85 to 50/35.The customer reports that this could however not be explained by a newly constructed pneumoperitoneum.'the customer reports that the surgeon was informed, no changes in intra -abdominal pressure.However, the customer reports it is inevitable that there are strong increase in intra- abdominal pressure occurred; supposedly seen big swings and blood pressure ventilation pressures clearly.The customer reports that this can be allegedly observed from the trends in the anesthesia file.The customer reports that there are to their knowledge no complications occurred in the patient due to these two phases of low acute venous return with low output as a result.The customer reports that these could not be anticipated and not in relation with a new installed pneumoperitoneum of 14mmhg.The customer reports that the combination of changes both airway pressure and decreased venous return indicate that the insufflator allegedly realized a higher pressure and showed on the screen.

Manufacturer Narrative

The reported device was not received for investigation; therefore the reported failure cannot be confirmed.The complaint will be closed without a detailed investigation report and based on probable root cause.In the event that the device is received, the complaint will be reopened, a full evaluation will be conducted, and the investigation will be updated with the new results.Probable root cause for the reported failure involving this device could have been probably caused by: bad lpu/hpu, bad pressure sensors or pressure control valves, use error, over due for calibration.In sum, the reported failure could not be confirmed since the device was not received at stryker endoscopy for investigation.

Event Description

It was reported that the anesthetist experienced problems during a laparoscopic cholecystectomy.Within the first two minutes, tachycardia and a fall in blood pressure was observed with low output.It was further reported that a severe hypotension out of proportion compared with the usual hypotension due to pneumoperitoneum.The company representative assumed that the patient was tied.Once the surgeon started the dissection no hemodynamic problems; very stable.The customer reports acute respiratory increase peak pressure 15mmhg, without cause, immediately afterwards co2 drop so again with acute drop in blood pressure of 130/85 to 50/35.The customer reports that this could; however, not be explained by a newly constructed pneumoperitoneum.'the customer reports that the surgeon was informed, no changes in intra -abdominal pressure.However, the customer reports it is inevitable that there are strong increase in intra- abdominal pressure occurred; supposedly seen big swings and blood pressure ventilation pressures clearly.The customer reports that this can be allegedly observed from the trends in the anesthesia file.The customer reports that there are to their knowledge no complications occurred in the patient due to these two phases of low acute venous return with low output as a result.The customer reports that these could not be anticipated and not in relation with a new installed pneumoperitoneum of 14mmhg.The customer reports that the combination of changes both airway pressure and decreased venous return indicate that the insufflator allegedly realized a higher pressure and showed on the screen.

Manufacturer Narrative

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

• Brand Name: PNEUMO SURE INCL. MANUAL: EN
• 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: thomas shafer ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 3775147
• MDR Text Key: 4672912
• Report Number: 0002936485-2014-00269
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K063367
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/30/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 620040601SSP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/30/2013
• Initial Date FDA Received: 04/28/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/20/2014
• Was Device Evaluated by Manufacturer?: No
• 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