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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, 1588 AIM CAMERA HEAD, C-MOUNT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY
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STRYKER ENDOSCOPY-SAN JOSE PKG, 1588 AIM CAMERA HEAD, C-MOUNT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Model Number 1588210105
Device Problems Poor Quality Image (1408); Product Quality Problem (1506)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/02/2020
Event Type  malfunction  
Manufacturer Narrative
Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.
 
Event Description
It was reported that there was image loss for about five minutes.
 
Manufacturer Narrative
The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.Alleged failure: threads worn down on both sides, falls right out during use.Root cause: camera head was previously repaired by a third party repair house.
 
Event Description
It was reported that there was image loss for about five minutes.
 
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Brand Name
PKG, 1588 AIM CAMERA HEAD, C-MOUNT
Type of Device
LAPAROSCOPE, GENERAL & PLASTIC SURGERY
Manufacturer (Section D)
STRYKER ENDOSCOPY-SAN JOSE
5900 optical court
san jose CA 95138
MDR Report Key10336130
MDR Text Key201363249
Report Number0002936485-2020-00309
Device Sequence Number1
Product Code GCJ
UDI-Device Identifier07613327174496
UDI-Public07613327174496
Combination Product (y/n)N
PMA/PMN Number
K132785
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 09/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1588210105
Device Catalogue Number1588210105
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/15/2020
Date Manufacturer Received07/02/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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