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

Catalog Number 0250070500

Device Problems Complete Blockage (1094); Suction Problem (2170)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/06/2023

Event Type  malfunction  

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 there was clogging during procedure.

Event Description

It was reported that there was clogging during procedure.

Manufacturer Narrative

This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: evacuation functions intermittently.Probable root cause: 1.Material/design error 2.Constant irrigation flow is not maintained leading to limited field of view 3.Stopcocks in improper configuration 4.Large anatomy 5.Missing o-ring 6.Damaged or deformed o-ring 7.Pump malfunction (motor, control board, harness, power supply, battery, or cassette) 8.Clogged tubing 9.Manufacturing/ service error 10.User error.The reported failure mode will be monitored for future reoccurrence.Please note we are discontinuing the current practice of filing malfunction medical device reports (mdrs) for reported complaints related to clogging on suction/irrigators.The suction/irrigator is designed to be used with a laparoscopic probe to allow for controlled irrigation and suction during laparoscopic surgical procedures.It is a sterile, single-use, and disposable battery-powered unit.This malfunction has not caused or contributed to any further deaths or serious injuries since march 2, 2020.Based on the information provided, it has been determined that this malfunction is unlikely to cause or contribute to death or serious injury should the malfunction recur.We will discontinue filing mdrs for suction/irrigators due to clogging.We will continue filing on clogging on suction/irrigators for the next 30 calendar days of this notification.If we do not receive a response within 30 calendar days of this letter, we will understand this as a concurrence with the decision to discontinue reporting these malfunctions.

• Brand Name: PKG., ASSY., SUCTION / IRRIGATOR 2
• 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: chester rebugio ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 16828544
• MDR Text Key: 314166592
• Report Number: 0002936485-2023-00358
• Device Sequence Number: 1
• Product Code: GCX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K934094
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0250070500
• Device Lot Number: 22144FG2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2022
• 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