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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG.,HEATED INSUFLATOR TUBE SET; INSUFFLATOR, LAPAROSCOPIC
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STRYKER ENDOSCOPY-SAN JOSE PKG.,HEATED INSUFLATOR TUBE SET; INSUFFLATOR, LAPAROSCOPIC Back to Search Results
Catalog Number 0620030407
Device Problem Insufficient Information (3190)
Patient Problem Burn(s) (1757)
Event Date 06/27/2017
Event Type  Injury  
Manufacturer Narrative
Additional information will be provided once the investigation has been completed.Mfg date: the device manufacture 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 patient may have been burned.Please note that further information received stated that the patient did not have any pain and medical intervention was not required.The procedure was completed successfully.
 
Manufacturer Narrative
The product was returned for investigation and the reported failure mode was not confirmed.Alleged failure: the tube set may have slightly burned the patient where it laid on the bare skin.The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.There is no probable root cause to the unit as no visible damage was noticed and it passed the specific, functional temperature tests for this product.Therefore, this unit is deemed as no problem found.The reported failure mode will be monitored for future reoccurrence.(b)(4).
 
Event Description
It was reported that the patient may have been burned.Please note that further information received stated that the patient did not have any pain and medical intervention was not required.The procedure was completed successfully.
 
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Brand Name
PKG.,HEATED INSUFLATOR TUBE SET
Type of Device
INSUFFLATOR, LAPAROSCOPIC
Manufacturer (Section D)
STRYKER ENDOSCOPY-SAN JOSE
5900 optical court
san jose CA 95138
Manufacturer (Section G)
STRYKER ENDOSCOPY-SAN JOSE
5900 optical court
san jose CA 95138
Manufacturer Contact
sandhya jaishankar
5900 optical court
san jose, CA 95138
4087542000
MDR Report Key6853327
MDR Text Key85455870
Report Number0002936485-2017-00848
Device Sequence Number1
Product Code HIF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K003792
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 01/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0620030407
Device Lot Number17119FE2
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/20/2017
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/28/2017
Initial Date FDA Received09/08/2017
Supplement Dates Manufacturer Received06/28/2017
Supplement Dates FDA Received01/23/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/29/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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