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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG., ASSY., SUCTION / IRRIGATOR 2; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

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STRYKER ENDOSCOPY-SAN JOSE PKG., ASSY., SUCTION / IRRIGATOR 2; LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Catalog Number 0250070500
Device Problem Smoking (1585)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/28/2021
Event Type  malfunction  
Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
 
Event Description
It was reported that the product emitted smoke.
 
Event Description
It was reported that the product emitted smoke.
 
Manufacturer Narrative
The product was not returned for investigation and the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.Alleged failure: device emitting smoke.Probable root cause: insulation melting.Excessive cauterization.Manufacturing/assembly/ service error.User error.Nonconforming electrical components.H3 other text : 81.
 
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Brand Name
PKG., ASSY., SUCTION / IRRIGATOR 2
Type of Device
LAPAROSCOPE, GENERAL & PLASTIC SURGERY
Manufacturer (Section D)
STRYKER ENDOSCOPY-SAN JOSE
5900 optical court
san jose CA 95138
MDR Report Key12229816
MDR Text Key265560327
Report Number0002936485-2021-00399
Device Sequence Number1
Product Code GCJ
UDI-Device Identifier37613327061391
UDI-Public37613327061391
Combination Product (y/n)N
PMA/PMN Number
K934094
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 10/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0250070500
Device Lot Number21097FG2
Was Device Available for Evaluation? No
Date Manufacturer Received06/28/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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