MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE FLUID SAFE VERSION EU 2; INSUFFLATOR, HYSTEROSCOPIC

Catalog Number 0502000004

Device Problem Device Inoperable (1663)

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

Event Date 06/24/2016

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.(b)(4).

Event Description

It was reported that the pump stopped functioning during surgery.The surgery was cancelled.

Manufacturer Narrative

(b)(4).Alleged failure: " during a surgery, no dilatation of the uterine cavity.No pressure.The surgeon and the medical staff had to complete the procedure manually which led to a long surgical delay (1 hour)".The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.The probable root causes could be pump height, surgery height, tubing was kinked, or a very narrow instrument was used.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 the pump stopped functioning during surgery.The surgery was cancelled.

• Brand Name: FLUID SAFE VERSION EU 2
• Type of Device: INSUFFLATOR, HYSTEROSCOPIC
• 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: 5851209
• MDR Text Key: 51295537
• Report Number: 0002936485-2016-00721
• Device Sequence Number: 1
• Product Code: HIG
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K022449
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0502000004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2016
• 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