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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, METZENBAUM SCISSORS, CURVED LONG; ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED

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STRYKER ENDOSCOPY-SAN JOSE PKG, METZENBAUM SCISSORS, CURVED LONG; ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED Back to Search Results
Model Number 0250080265
Device Problem Break (1069)
Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)
Event Date 11/19/2019
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.
 
Event Description
It was reported that the tip of the scissor broke off.The broken pieces were retrieved.
 
Event Description
It was reported that the tip of the scissor broke off.The broken pieces were retrieved.
 
Manufacturer Narrative
This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: tip broke.Probable root cause: poor autoclave reliability.Shear pin failure in handle.Use error.Damage during manufacturing/ servicing.The reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.H3 other text : 81.
 
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Brand Name
PKG, METZENBAUM SCISSORS, CURVED LONG
Type of Device
ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED
Manufacturer (Section D)
STRYKER ENDOSCOPY-SAN JOSE
5900 optical court
san jose CA 95138
MDR Report Key9474606
MDR Text Key176826015
Report Number0002936485-2019-00559
Device Sequence Number1
Product Code OCZ
UDI-Device Identifier07613327052633
UDI-Public07613327052633
Combination Product (y/n)N
PMA/PMN Number
K973259
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 02/20/2020
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 Health Professional
Device Model Number0250080265
Device Catalogue Number0250080265
Device Lot NumberNR
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/19/2019
Initial Date FDA Received12/16/2019
Supplement Dates Manufacturer Received11/19/2019
Supplement Dates FDA Received02/20/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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