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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG; HEATED TUBESET WITH RTP FOR PNEUMO SURE (10-PK); INSUFFLATOR, LAPAROSCOPIC
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STRYKER ENDOSCOPY-SAN JOSE PKG; HEATED TUBESET WITH RTP FOR PNEUMO SURE (10-PK); INSUFFLATOR, LAPAROSCOPIC Back to Search Results
Catalog Number 0620040690
Device Problems Disconnection (1171); Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/11/2019
Event Type  malfunction  
Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
 
Event Description
It was reported that there was loss of insufflation due to insufflation tubing leaking and disconnecting.
 
Manufacturer Narrative
Alleged failure: tubing couldn't connect to unsufflator properly so co2 leaked the failure(s) identified in the investigation is consistent with the complaint record.The probable root cause could be manufacturing.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
 
Event Description
It was reported that there was loss of insufflation due to insufflation tubing leaking and disconnecting.
 
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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
MDR Report Key8592661
MDR Text Key144545328
Report Number0002936485-2019-00192
Device Sequence Number1
Product Code HIF
UDI-Device Identifier37613327055659
UDI-Public37613327055659
Combination Product (y/n)N
PMA/PMN Number
K003792
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 08/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/08/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0620040690
Device Lot Number18K0376
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/20/2019
Date Manufacturer Received04/11/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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