MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE UNKNOWN_ENDOSCOPY_PRODUCT; INSUFFLATOR, LAPAROSCOPIC

Catalog Number UNK_END

Device Problem Air Leak (1008)

Patient Problems Laceration(s) (1946); Injury (2348)

Event Date 10/26/2011

Event Type  Injury  

Event Description

Per legal document, on (b)(6), 2011, the patient at largo medical center received cardiac convergent procedure, during which the patient sustained an injury to his heart.Legal further indicated that the patient alleges that the surgeon lacerated his heart and also failed to disconnect the insufflator pump.Additional information - the dr has claimed that air came out of the insufflator and caused cut in the heart, not his own surgical instrument.

Manufacturer Narrative

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

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 caused by: 1.Pressure sensor malfunction / out of calibration; 2.Software malfunction; 3.Use error; 4.System design; 5.Unwanted movement of internal components / wiring; 6.Insufflator operated at least-favorable environmental conditions for an extended period of time.7.Power button inadvertently turned off.8.Tubeset/gas supply inadvertently detached/loose.9.Loss of power.10.Pressure button does not disengage.11.Inlet/outlet gas connectors not connected properly.12.Insufflator accessories not connected properly.In sum, the reported failure could not be confirmed since the device was not received at stryker endoscopy for investigation.The product was not returned for investigation therefore the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.

Event Description

Per legal document, on 26-oct-2011, the patient at (b)(6) medical center received cardiac convergent procedure, during which the patient sustained an injury to his heart.Legal further indicated that the patient alleges that the surgeon lacerated his heart and also failed to disconnect the insufflator pump.Additional information - the dr has claimed that air came out of the insufflator and caused cut in the heart, not his own surgical instrument.

• Brand Name: UNKNOWN_ENDOSCOPY_PRODUCT
• 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: kimberly lynch ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 4793421
• MDR Text Key: 20146517
• Report Number: 0002936485-2015-00419
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063367
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,consumer,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/28/2015

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: UNK_END
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/28/2015
• Initial Date FDA Received: 05/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention