MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG; HEATED TUBESET WITH RTP FOR PNEUMO SURE (10-PK); INSUFFLATOR, LAPAROSCOPIC

Catalog Number 0620040690

Device Problem Disconnection (1171)

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

Event Date 09/22/2018

Event Type  malfunction  

Manufacturer Narrative

The product was not returned for investigation therefore the reported failure mode was not confirmed.The reported failure mode will be monitored for future reoccurrence.Alleged failure: tubing coming detached from the cassette.Probable root cause: system design (tolerance stack up issue).Manufacturing / assembly error.Use error.Damage during shipping (inadequate packaging).Damage during shipping (abuse during transit).The device manufacture date is not known.

Event Description

It was reported that the insufflation tubing disconnected during the procedure.

• Brand Name: PKG; HEATED TUBESET WITH RTP FOR PNEUMO SURE (10-PK)
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• 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: 8289674
• MDR Text Key: 134574842
• Report Number: 0002936485-2019-00040
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 37613327055659
• UDI-Public: 37613327055659
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K003792
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/30/2019

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: Health Professional
• Device Catalogue Number: 0620040690
• Device Lot Number: 56005175
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/22/2018
• Initial Date FDA Received: 01/30/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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