RESCUE
Received Sep 24, 2020 · Event occurred Aug 28, 2020
Report 3005099803-2020-04028 · MDR key 10581109
Device
Generic name
Endoscopic Grasping/cutting Instrument, Non-powered
Manufacturer
Boston Scientific CorporationModel number
M00538351Catalog number
3835
Lot number
2019082901
Product problems
- Tear, Rip or Hole in Device Packaging
- Tear, Rip or Hole in Device Packaging
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
BLOCK A2: PATIENT'S EXACT AGE IS UNKNOWN; HOWEVER IT WAS REPORTED THAT THE PATIENT WAS OVER THE AGE OF 18. BLOCK H6: DEVICE CODE 2385 CAPTURES THE REPORTABLE EVENT OF TORN PACKAGING. BLOCK H10: VISUAL ANALYSIS FOUND ALL THE SEALS EXTERNAL OF THE BOX WERE NOT BROKEN AND THE UNIT WAS SEALED. AN INDENTED SCRAPE WAS FOUND ON ONE SIDE BUT DID NOT FULLY PUNCTURE THE BOX. THE PRODUCT INSIDE THE BOX WAS CONFIRNED TO BE NOT DAMAGED (TORN) AND THE PACKAGING WAS SEALED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. BASED ON ALL AVAILABLE INFORMATION, IT IS UNLIKELY THAT THE REPORTED EVENT IS DUE TO A MANUFACTURING ISSUE. IT IS POSSIBLE THAT THE BOX WAS SCRAPED AS IT WAS SHIPPED AND TRANSPORTED FROM THE MANUFACTURE SITE TO THE CUSTOMER. THEREFORE, THE MOST LIKELY ROOT CAUSE IS CAUSED TRACED TO TRANSPORT/STORAGE, WHICH INDICATES THAT PROBLEM MAY BE TRACED TO TRANSPORT OR STORAGE OF THE DEVICE.
Description of Event or Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESCUE RETRIEVAL FORCEPS WAS TO BE USED IN A PROCEDURE ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, SCRATCHES WERE FOUND ON THE SIDE OF THE WHITE PRODUCT PACKAGING AND WAS TORN OUT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Additional Manufacturer Narrative
PATIENT'S EXACT AGE IS UNKNOWN; HOWEVER IT WAS REPORTED THAT THE PATIENT WAS OVER THE AGE OF 18. (B)(4). THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MDR WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESCUE RETRIEVAL FORCEPS WAS TO BE USED IN A PROCEDURE ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, SCRATCHES WERE FOUND ON THE SIDE OF THE WHITE PRODUCT PACKAGING AND WAS TORN OUT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.