MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, 40L CORE SIDNE READY INSUFFLATOR; INSUFFLATOR, LAPAROSCOPIC

Catalog Number 0620040504

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

Patient Problem Pain (1994)

Event Date 05/31/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient extended their stay because of post op pain.

Manufacturer Narrative

The product was returned for investigation and the reported failure mode was not confirmed.The reported failure mode will be monitored for future reoccurrence.Alleged failure: patient extended their stay because of pain the failure alleged in the complaint record was not confirmed/duplicated during the product investigation.There is no probable root cause in relation to the complaint as the unit performed to specification with no errors observed as per the customer complaint.However, the unit is past due for calibration and preventative maintenance.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.The device manufacture date is not known.

Event Description

It was reported that the patient extended their stay because of post op pain.

• Brand Name: PKG, 40L CORE SIDNE READY INSUFFLATOR
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 8776191
• MDR Text Key: 150564994
• Report Number: 0002936485-2019-00283
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• PMA/PMN Number: K063367
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 0620040504
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2019
• Date Manufacturer Received: 06/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other