MAUDE Adverse Event Report: STRYKER ENDOSCOPY DIV. OF STRYKER CORP. PNEUMO SURE; INSUFFLATOR

Catalog Number 620-040-660

Device Problem Material Separation (1562)

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

Event Date 07/30/2014

Event Type  malfunction  

Event Description

Attachment piece of insufflation tubing came apart during surgery.

• Brand Name: PNEUMO SURE
• Type of Device: INSUFFLATOR
• Manufacturer (Section D): STRYKER ENDOSCOPY DIV. OF STRYKER CORP.; 5900 optical ct; san jose CA 95138
• MDR Report Key: 4120585
• MDR Text Key: 4796366
• Report Number: 4120585
• Device Sequence Number: 1
• Product Code: HIF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 09/05/2014

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: Physician
• Device Catalogue Number: 620-040-660
• Device Lot Number: 56006005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2014
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/05/2014
• Event Location: Hospital
• Date Report to Manufacturer: 09/26/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/05/2014
• Patient Sequence Number: 1
• Patient Age: 72 YR