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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG. MONOPOLAR ELECTROSURGICAL PROBE, L-TIP, 33CM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY
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STRYKER ENDOSCOPY-SAN JOSE PKG. MONOPOLAR ELECTROSURGICAL PROBE, L-TIP, 33CM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Catalog Number 0250040112
Device Problem Device Packaging Compromised (2916)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/17/2018
Event Type  malfunction  
Manufacturer Narrative
The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.Additional information will be provided once the investigation has been completed.(b)(4).
 
Event Description
It was reported that the insulation had been compromised.
 
Manufacturer Narrative
Alleged failure: the outer skin of the hook has some expensed mental the failure(s) identified in the investigation is consistent with the complaint record.The probable root cause could be handling during cleaning/sterilization.The product was returned for investigation and the failure mode was confirmed and will be monitored for future reoccurrence.The device manufacture date is not known.
 
Event Description
It was reported that the insulation had been compromised.
 
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Brand Name
PKG. MONOPOLAR ELECTROSURGICAL PROBE, L-TIP, 33CM
Type of Device
LAPAROSCOPE, GENERAL & PLASTIC SURGERY
Manufacturer (Section D)
STRYKER ENDOSCOPY-SAN JOSE
5900 optical court
san jose CA 95138
MDR Report Key7517142
MDR Text Key108487240
Report Number0002936485-2018-00427
Device Sequence Number1
Product Code GCJ
Combination Product (y/n)N
PMA/PMN Number
K934094
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 03/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/15/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number0250040112
Device Lot Number228908
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/10/2018
Date Manufacturer Received04/17/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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