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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 Problem Contamination /Decontamination Problem (2895)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/27/2018
Event Type  malfunction  
Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
 
Event Description
It was reported that there was foreign material inside of the sterile packaging.
 
Manufacturer Narrative
Alleged failure: (b)(4) hair in the sterile packaging salesforce case number (b)(4).The failure(s) identified in the investigation is consistent with the complaint record.The probable root cause could be foreign material fell inside during packaging.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.The device manufacturer date is not known.
 
Event Description
It was reported that there was foreign material inside of the sterile packaging.
 
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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 Key8190544
MDR Text Key131337955
Report Number0002936485-2018-00723
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 03/15/2019
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 Other
Device Catalogue Number0620040690
Device Lot Number56005887
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/22/2019
Initial Date Manufacturer Received 11/27/2018
Initial Date FDA Received12/21/2018
Supplement Dates Manufacturer Received11/27/2018
Supplement Dates FDA Received03/15/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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