PERI-STRIPS DRY WITH VERITASWITH SECURE GRIP PSDA60ECHRecalls & reported problems
Synovis Life Technologies, Inc. · PSDV-SG is prepared from dehydrated bovine pericardium procured from cattle under 30 months of age in the U.S. The product consists of a loading unit which includes two buttresses. Each buttress has acrylic adhesive on one side for attachment to the stapler surfaces. Each PSDV-SG loading unit is packaged sterile in a separate pouch. PSDV-SG is MR Safe. · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00085412658803), received between Jul 21, 2020 and Aug 21, 2020 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Disconnection” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Disconnection1
- Improper or Incorrect Procedure or Method1
Patient problems
- Foreign Body In Patient1
- No Consequences Or Impact To Patient1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 21, 2020Disconnection; Disconnection
IT WAS REPORTED THAT THE PERI-STRIP DID NOT ADHERE TO THE STAPLER; FURTHER DESCRIBED AS ¿THEY DID NOT ALLOW IT TO DRY OFF THE STAPLER WELL ENOUGH¿. THIS WAS IDENTIFIED PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Patient Involvement
MAUDE report 10437630 ↗InjuryJul 21, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
IT WAS REPORTED THAT A PERI-STRIP SECURE GRIP WAS "GELLED OVER" AND THE PLASTIC STRIP (LINER) WAS NOT REMOVED FROM THE SECURE GRIP; THE PERI-STRIP WAS APPLIED ONTO THE STAPLER. IT WAS FURTHER REPORTED THAT THE SURGEON STAPLED WITH THE PLASTIC STRIP STILL ON THE PERI-STRIP. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient
MAUDE report 10302664 ↗
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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