Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE SLINGSHOT 70 DEG UP; PASSER
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STRYKER ENDOSCOPY-SAN JOSE SLINGSHOT 70 DEG UP; PASSER Back to Search Results
Catalog Number CAT02590
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/31/2018
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.(b)(4).
 
Event Description
It was reported that the product broke.The broken piece was successfully retrieved.
 
Manufacturer Narrative
The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Alleged failure: broken slingshot during capsule closure.The failure identified in the investigation is consistent with the complaint record.The probable root causes could be: 1) user applied excessive force on device or 2) difficult anatomy, extremely tough soft tissue.Manufacture date is not known.Gtin: (b)(4).
 
Event Description
It was reported that the product broke.The broken piece was successfully retrieved.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SLINGSHOT 70 DEG UP
Type of Device
PASSER
Manufacturer (Section D)
STRYKER ENDOSCOPY-SAN JOSE
5900 optical court
san jose CA 95138
MDR Report Key7305493
MDR Text Key101365783
Report Number0002936485-2018-00202
Device Sequence Number1
Product Code HWQ
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 06/13/2018
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 Catalogue NumberCAT02590
Device Lot Number002873
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/23/2018
Initial Date Manufacturer Received 02/02/2018
Initial Date FDA Received02/28/2018
Supplement Dates Manufacturer Received02/02/2018
Supplement Dates FDA Received06/13/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-