MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG., ASSY., STRYKEFLOW 2 WITH TIP; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Catalog Number 0250070520

Device Problem Fluid/Blood Leak (1250)

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

Event Date 04/14/2017

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.(b)(4).

Event Description

It was reported that battery fluid dripped on user.

Manufacturer Narrative

The product was not returned for investigation therefore the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.Alleged failure: acid drip.Probable root cause: material/design error, use of incompatible equipment, missing o-ring, damaged or deformed o-ring, user error in assembling or using equipment with a loose connection, pump malfunction, clogged tubing.(b)(4).

Event Description

It was reported that battery fluid dripped on user.

• Brand Name: PKG., ASSY., STRYKEFLOW 2 WITH TIP
• Type of Device: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• 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: valerie estrada ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 6561861
• MDR Text Key: 75103309
• Report Number: 0002936485-2017-00442
• Device Sequence Number: 1
• Product Code: GCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K954726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0250070520
• Device Lot Number: 16364FG2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/29/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1