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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
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 05/30/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Alleged failure: the flow wouldn¿t stay consistent, pressure kept hoping around and losing vision the failure identified in the investigation is consistent with the complaint record.The probable root causes could be extreme shipping/storage conditions, or manufacturing.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
 
Event or Problem Description
It was reported that there was loss of insufflation during the procedure.
 
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Brand Name
PKG; HEATED TUBESET WITH RTP FOR PNEUMO SURE (10-PK)
Common Device Name
INSUFFLATOR, LAPAROSCOPIC
Manufacturer (Section D)
STRYKER ENDOSCOPY-SAN JOSE
5900 optical court
san jose CA 95138
MDR Report Key8563343
Report Number0002936485-2019-00166
Device Sequence Number16642361
Product Code HIF
UDI-Device Identifier37613327055659
UDI-Public37613327055659
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K003792
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 04/29/2019
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
Operator of Device Health Professional
Device Catalogue Number0620040690
Device Lot Number17K0358
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/28/2018
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/01/2018
Initial Report FDA Received Date04/30/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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